[ { "trial": "T01", "entries": [ { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Niger", "estimate": { "measure": "percent reduction", "value": 18.1, "lower": 10.0, "upper": 25.5, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": 40345, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": 35747, "rate_per_1000_person_years": 27.5, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:29694816 Results (Subgroup results; placebo rate from Primary results; children from Table 1, baseline)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Niger", "estimate": { "measure": "hazard ratio", "value": 0.81, "lower": 0.75, "upper": 0.87, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:30561577 Results (Cox proportional hazard model, stratified by country)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "year 1", "subgroup": "Niger", "estimate": { "measure": "percent reduction", "value": 16.0, "lower": 5.7, "upper": 25.1, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 21.9, "rate_lower": 20.2, "rate_upper": 24.2 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 26.3, "rate_lower": 24.2, "rate_upper": 28.8 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:31167050 Table 2 (MORDOR I, distribution year 1; difference between arms, randomized comparison)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "year 2", "subgroup": "Niger", "estimate": { "measure": "percent reduction", "value": 20.3, "lower": 10.6, "upper": 28.9, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 22.4, "rate_lower": 20.6, "rate_upper": 24.3 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 28.0, "rate_lower": 25.8, "rate_upper": 30.5 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:31167050 Table 2 (MORDOR I, distribution year 2; difference between arms, randomized comparison)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "extension", "subgroup": "Niger", "estimate": { "measure": "percent reduction", "value": 3.5, "lower": -8.3, "upper": 14, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": 37497, "rate_per_1000_person_years": 23.3, "rate_lower": 21.4, "rate_upper": 25.5 }, "control": { "deaths": null, "person_years": null, "children": 33294, "rate_per_1000_person_years": 24.0, "rate_lower": 22.1, "rate_upper": 26.3 }, "adjusted_for_clustering": null, "primary": true, "where": "pmid:31167050 Table 2 (MORDOR II, distribution year 3, both arms given azithromycin) and Results (Primary outcome); children from Table 1 (start of MORDOR II)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-60 months", "period": "extension", "subgroup": "Niger", "estimate": null, "treated": { "deaths": null, "person_years": null, "children": 37497, "rate_per_1000_person_years": 23.3, "rate_lower": 21.4, "rate_upper": 25.5 }, "control": { "deaths": null, "person_years": null, "children": 33294, "rate_per_1000_person_years": 24.0, "rate_lower": 22.1, "rate_upper": 26.3 }, "adjusted_for_clustering": null, "primary": true, "where": "NCT02047981 posted results, primary outcome 'All-cause Mortality Rate in Children Aged 1-60 Months', time frame 36 months (contingency study in Niger only, all communities given azithromycin in year 3)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Niger", "estimate": null, "treated": { "deaths": 1727, "person_years": null, "children": 40345, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 1888, "person_years": null, "children": 35747, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:31981558 Results text (child deaths documented over 2 years of biannual censuses; children enrolled at baseline)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Niger", "estimate": { "measure": "incidence rate ratio", "value": 0.82, "lower": 0.75, "upper": 0.9, "level": 0.95 }, "treated": { "deaths": 1566, "person_years": null, "children": null, "rate_per_1000_person_years": 22.32, "rate_lower": 20.86, "rate_upper": 23.87 }, "control": { "deaths": 1735, "person_years": null, "children": null, "rate_per_1000_person_years": 27.26, "rate_lower": 25.5, "rate_upper": 29.13 }, "adjusted_for_clustering": true, "primary": false, "where": "pmid:31981558 Table 3, Total row (deaths with a cause ascertained by verbal autopsy only; negative binomial regression of community-level death counts)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-60 months", "period": "whole", "subgroup": "Niger", "estimate": null, "treated": { "deaths": null, "person_years": null, "children": 40345, "rate_per_1000_person_years": 22.3, "rate_lower": 20.9, "rate_upper": 23.9 }, "control": { "deaths": null, "person_years": null, "children": 35747, "rate_per_1000_person_years": 27.3, "rate_lower": 25.5, "rate_upper": 29.1 }, "adjusted_for_clustering": null, "primary": false, "where": "NCT02047981 posted results, secondary outcome 'Cause-specific Mortality Rate ... Verbal Autopsy (Niger Only)', Total row, time frame 24 months" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Niger", "estimate": null, "treated": { "deaths": null, "person_years": null, "children": 40345, "rate_per_1000_person_years": 22.5, "rate_lower": 21.4, "rate_upper": 23.5 }, "control": { "deaths": null, "person_years": null, "children": 35747, "rate_per_1000_person_years": 27.5, "rate_lower": 26.2, "rate_upper": 28.7 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:38100110 Results text ('As previously reported, overall mortality rates'); children from Table 1" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Niger, 0 km from the nearest primary health center", "estimate": { "measure": "incidence rate ratio", "value": 1.0, "lower": 0.83, "upper": 1.19, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:38100110 Table 2 (azithromycin vs placebo within strata of distance; negative binomial regression adjusted for community mean age) and Results text" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Niger, 1 km from the nearest primary health center", "estimate": { "measure": "incidence rate ratio", "value": 0.96, "lower": 0.83, "upper": 1.12, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:38100110 Table 2 (azithromycin vs placebo within strata of distance) and Results text" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Niger, 5 km from the nearest primary health center", "estimate": { "measure": "incidence rate ratio", "value": 0.84, "lower": 0.77, "upper": 0.93, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:38100110 Table 2 (azithromycin vs placebo within strata of distance) and Results text" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Niger, 10 km from the nearest primary health center", "estimate": { "measure": "incidence rate ratio", "value": 0.72, "lower": 0.62, "upper": 0.83, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:38100110 Table 2 (azithromycin vs placebo within strata of distance) and Results text" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Niger", "estimate": { "measure": "incidence rate ratio", "value": 0.82, "lower": 0.74, "upper": 0.9, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:34508582 abstract, Background (intention-to-treat result of the trial in Niger)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Niger, treated children (complier average causal effect)", "estimate": { "measure": "incidence rate ratio", "value": 0.8, "lower": 0.72, "upper": 0.88, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 16.6, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 20.9, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:34508582 abstract, Results" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Niger, untreated children (spillover)", "estimate": { "measure": "incidence rate ratio", "value": 0.91, "lower": 0.69, "upper": 1.21, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 33.6, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 34.4, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:34508582 abstract, Results" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-11 months", "period": "whole", "subgroup": "Niger, children with a valid weight recorded at first census", "estimate": { "measure": "rate ratio", "value": 0.72, "lower": 0.62, "upper": 0.83, "level": 0.95 }, "treated": { "deaths": 523, "person_years": 16153, "children": 14243, "rate_per_1000_person_years": 32.4, "rate_lower": 29.3, "rate_upper": 35.5 }, "control": { "deaths": 661, "person_years": 14699, "children": 12979, "rate_per_1000_person_years": 45.0, "rate_lower": 40.3, "rate_upper": 49.7 }, "adjusted_for_clustering": true, "primary": false, "where": "pmid:32931496 Table 2, Overall row (CIs by bootstrap resampling at the community level)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-11 months", "period": "whole", "subgroup": "Niger, WAZ ≥ −2", "estimate": { "measure": "rate ratio", "value": 0.73, "lower": 0.61, "upper": 0.87, "level": 0.95 }, "treated": { "deaths": 387, "person_years": 12610, "children": 10988, "rate_per_1000_person_years": 30.7, "rate_lower": 27.0, "rate_upper": 34.4 }, "control": { "deaths": 480, "person_years": 11435, "children": 9966, "rate_per_1000_person_years": 42.0, "rate_lower": 36.9, "rate_upper": 47.3 }, "adjusted_for_clustering": true, "primary": false, "where": "pmid:32931496 Table 2 (WAZ category, moderate to severe)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-11 months", "period": "whole", "subgroup": "Niger, WAZ < −2 (moderate to severe underweight)", "estimate": { "measure": "rate ratio", "value": 0.69, "lower": 0.54, "upper": 0.86, "level": 0.95 }, "treated": { "deaths": 136, "person_years": 3543, "children": 3255, "rate_per_1000_person_years": 38.4, "rate_lower": 32.4, "rate_upper": 44.9 }, "control": { "deaths": 181, "person_years": 3264, "children": 3013, "rate_per_1000_person_years": 55.4, "rate_lower": 46.7, "rate_upper": 64.9 }, "adjusted_for_clustering": true, "primary": false, "where": "pmid:32931496 Table 2 (WAZ category, moderate to severe)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-11 months", "period": "whole", "subgroup": "Niger, WAZ ≥ −3", "estimate": { "measure": "rate ratio", "value": 0.74, "lower": 0.63, "upper": 0.84, "level": 0.95 }, "treated": { "deaths": 460, "person_years": 14599, "children": 12796, "rate_per_1000_person_years": 31.5, "rate_lower": 28.3, "rate_upper": 35.0 }, "control": { "deaths": 568, "person_years": 13293, "children": 11671, "rate_per_1000_person_years": 42.7, "rate_lower": 37.6, "rate_upper": 47.6 }, "adjusted_for_clustering": true, "primary": false, "where": "pmid:32931496 Table 2 (WAZ category, severe)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-11 months", "period": "whole", "subgroup": "Niger, WAZ < −3 (severe underweight)", "estimate": { "measure": "rate ratio", "value": 0.61, "lower": 0.44, "upper": 0.84, "level": 0.95 }, "treated": { "deaths": 63, "person_years": 1554, "children": 1447, "rate_per_1000_person_years": 40.5, "rate_lower": 30.9, "rate_upper": 49.7 }, "control": { "deaths": 93, "person_years": 1406, "children": 1308, "rate_per_1000_person_years": 66.1, "rate_lower": 53.7, "rate_upper": 79.4 }, "adjusted_for_clustering": true, "primary": false, "where": "pmid:32931496 Table 2 (WAZ category, severe)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-11 months", "period": "whole", "subgroup": "Niger, WAZ ≥ −2", "estimate": { "measure": "hazard ratio", "value": 0.73, "lower": 0.62, "upper": 0.85, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:32931496 Table 3 (Cox proportional hazards sensitivity analysis, azithromycin within strata of WAZ)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-11 months", "period": "whole", "subgroup": "Niger, WAZ < −2 (moderate to severe underweight)", "estimate": { "measure": "hazard ratio", "value": 0.7, "lower": 0.55, "upper": 0.89, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:32931496 Table 3 (Cox proportional hazards sensitivity analysis, azithromycin within strata of WAZ) and Results text" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-11 months", "period": "whole", "subgroup": "Niger, WAZ ≥ −3", "estimate": { "measure": "hazard ratio", "value": 0.74, "lower": 0.64, "upper": 0.85, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:32931496 Table 3 (Cox proportional hazards sensitivity analysis, azithromycin within strata of WAZ)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-11 months", "period": "whole", "subgroup": "Niger, WAZ < −3 (severe underweight)", "estimate": { "measure": "hazard ratio", "value": 0.62, "lower": 0.45, "upper": 0.86, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:32931496 Table 3 (Cox proportional hazards sensitivity analysis, azithromycin within strata of WAZ) and Results text" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Malawi", "estimate": { "measure": "percent reduction", "value": 5.7, "lower": -9.7, "upper": 18.9, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": 39386, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": 39534, "rate_per_1000_person_years": 9.6, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:29694816 Results (Subgroup results; placebo rate from Primary results; children from Table 1, baseline)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Malawi", "estimate": { "measure": "hazard ratio", "value": 0.96, "lower": 0.84, "upper": 1.14, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:30561577 Results (Cox proportional hazard model, stratified by country)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Malawi", "estimate": { "measure": "rate ratio", "value": 0.91, "lower": 0.79, "upper": 1.05, "level": 0.95 }, "treated": { "deaths": null, "person_years": 66837, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": 66935, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:32342837 Results text (all-cause rate ratio); person-years per arm from Table 4" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Malawi", "estimate": null, "treated": { "deaths": 564, "person_years": "66.84 thousand", "children": 43105, "rate_per_1000_person_years": 8.44, "rate_lower": 7.77, "rate_upper": 9.16 }, "control": { "deaths": 620, "person_years": "66.93 thousand", "children": 42825, "rate_per_1000_person_years": 9.26, "rate_lower": 8.56, "rate_upper": 10.02 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:32342840 Table 4, Total column (person-years printed in thousands); children enrolled from Table 2" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Malawi, Monkey Bay zone", "estimate": null, "treated": { "deaths": 73, "person_years": "10.96 thousand", "children": null, "rate_per_1000_person_years": 6.66, "rate_lower": 5.3, "rate_upper": 8.38 }, "control": { "deaths": 53, "person_years": "7.58 thousand", "children": null, "rate_per_1000_person_years": 6.99, "rate_lower": 5.34, "rate_upper": 9.15 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:32342840 Table 4 (person-years printed in thousands)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Malawi, Chilipa zone", "estimate": null, "treated": { "deaths": 119, "person_years": "11.60 thousand", "children": null, "rate_per_1000_person_years": 10.26, "rate_lower": 8.57, "rate_upper": 12.28 }, "control": { "deaths": 134, "person_years": "12.28 thousand", "children": null, "rate_per_1000_person_years": 10.91, "rate_lower": 9.21, "rate_upper": 12.93 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:32342840 Table 4 (person-years printed in thousands)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Malawi, Makanjira zone", "estimate": null, "treated": { "deaths": 87, "person_years": "9.33 thousand", "children": null, "rate_per_1000_person_years": 9.32, "rate_lower": 7.56, "rate_upper": 11.5 }, "control": { "deaths": 89, "person_years": "10.08 thousand", "children": null, "rate_per_1000_person_years": 8.83, "rate_lower": 7.18, "rate_upper": 10.87 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:32342840 Table 4 (person-years printed in thousands)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Malawi, Namwera zone", "estimate": null, "treated": { "deaths": 135, "person_years": "17.59 thousand", "children": null, "rate_per_1000_person_years": 7.67, "rate_lower": 6.48, "rate_upper": 9.08 }, "control": { "deaths": 191, "person_years": "18.05 thousand", "children": null, "rate_per_1000_person_years": 10.58, "rate_lower": 9.18, "rate_upper": 12.19 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:32342840 Table 4 (person-years printed in thousands)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Malawi, Mangochi zone", "estimate": null, "treated": { "deaths": 150, "person_years": "17.36 thousand", "children": null, "rate_per_1000_person_years": 8.64, "rate_lower": 7.36, "rate_upper": 10.14 }, "control": { "deaths": 153, "person_years": "18.94 thousand", "children": null, "rate_per_1000_person_years": 8.08, "rate_lower": 6.89, "rate_upper": 9.46 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:32342840 Table 4 (person-years printed in thousands)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Tanzania", "estimate": { "measure": "percent reduction", "value": 3.4, "lower": -21.2, "upper": 23.0, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": 17316, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": 17910, "rate_per_1000_person_years": 5.5, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:29694816 Results (Subgroup results; placebo rate from Primary results; children from Table 1, baseline)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Tanzania", "estimate": { "measure": "hazard ratio", "value": 0.996, "lower": 0.8, "upper": 1.24, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:30561577 Results (Cox proportional hazard model, stratified by country)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Tanzania", "estimate": null, "treated": { "deaths": 190, "person_years": 32514, "children": null, "rate_per_1000_person_years": "0.58 per 100 person-years", "rate_lower": null, "rate_upper": null }, "control": { "deaths": 200, "person_years": 33638, "children": null, "rate_per_1000_person_years": "0.59 per 100 person-years", "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:34559801 Results text (rates printed per 100 person-years)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-5 months", "period": "whole", "subgroup": "Tanzania", "estimate": { "measure": "incidence rate ratio", "value": 0.8, "lower": 0.46, "upper": 1.39, "level": 0.95 }, "treated": { "deaths": 25, "person_years": 2190.1, "children": null, "rate_per_1000_person_years": "1.14 per 100 person-years", "rate_lower": null, "rate_upper": null }, "control": { "deaths": 32, "person_years": 2230.5, "children": null, "rate_per_1000_person_years": "1.43 per 100 person-years", "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": true, "primary": false, "where": "pmid:34559801 Table 1 (age group specific negative binomial regression at the community level; rates per 100 person-years)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "6-11 months", "period": "whole", "subgroup": "Tanzania", "estimate": { "measure": "incidence rate ratio", "value": 0.92, "lower": 0.57, "upper": 1.48, "level": 0.95 }, "treated": { "deaths": 42, "person_years": 3599.2, "children": null, "rate_per_1000_person_years": "1.17 per 100 person-years", "rate_lower": null, "rate_upper": null }, "control": { "deaths": 45, "person_years": 3597.1, "children": null, "rate_per_1000_person_years": "1.25 per 100 person-years", "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": true, "primary": false, "where": "pmid:34559801 Table 1 (age group specific negative binomial regression at the community level; rates per 100 person-years)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "12-23 months", "period": "whole", "subgroup": "Tanzania", "estimate": { "measure": "incidence rate ratio", "value": 1.03, "lower": 0.72, "upper": 1.48, "level": 0.95 }, "treated": { "deaths": 59, "person_years": 7564.1, "children": null, "rate_per_1000_person_years": "0.78 per 100 person-years", "rate_lower": null, "rate_upper": null }, "control": { "deaths": 60, "person_years": 7926.0, "children": null, "rate_per_1000_person_years": "0.76 per 100 person-years", "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": true, "primary": false, "where": "pmid:34559801 Table 1 (age group specific negative binomial regression at the community level; rates per 100 person-years)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "24-59 months", "period": "whole", "subgroup": "Tanzania", "estimate": { "measure": "incidence rate ratio", "value": 1.05, "lower": 0.74, "upper": 1.5, "level": 0.95 }, "treated": { "deaths": 64, "person_years": 19165.5, "children": null, "rate_per_1000_person_years": "0.33 per 100 person-years", "rate_lower": null, "rate_upper": null }, "control": { "deaths": 63, "person_years": 19888.5, "children": null, "rate_per_1000_person_years": "0.32 per 100 person-years", "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": true, "primary": false, "where": "pmid:34559801 Table 1 (age group specific negative binomial regression at the community level; rates per 100 person-years)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": null, "estimate": { "measure": "percent reduction", "value": 13.5, "lower": 6.7, "upper": 19.8, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": 97047, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": 93191, "rate_per_1000_person_years": 16.5, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": true, "primary": true, "where": "pmid:29694816 Results (Primary results: community-level, intention-to-treat analysis over all 4 inter-census periods); children from Table 1, baseline" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-5 months", "period": "whole", "subgroup": null, "estimate": { "measure": "percent reduction", "value": 24.9, "lower": 10.6, "upper": 37.0, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:29694816 Results (Subgroup results; Figure 3)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "first inter-census period", "subgroup": null, "estimate": { "measure": "percent reduction", "value": 7.3, "lower": -5.9, "upper": 18.8, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:29694816 Results (Subgroup results; Figure 4)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "last inter-census period", "subgroup": null, "estimate": { "measure": "percent reduction", "value": 22.0, "lower": 10.6, "upper": 31.9, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:29694816 Results (Subgroup results; Figure 4; the last of 4 inter-census periods)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-60 months", "period": "whole", "subgroup": null, "estimate": null, "treated": { "deaths": null, "person_years": null, "children": 97047, "rate_per_1000_person_years": 14.6, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": 93191, "rate_per_1000_person_years": 16.5, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": true, "where": "NCT02047981 posted results, primary outcome 'All-cause Mortality Rate in Children Aged 1-60 Months', time frame 24 months (no dispersion posted)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-60 months", "period": "whole", "subgroup": null, "estimate": null, "treated": { "deaths": 3262, "person_years": null, "children": 97047, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 3392, "person_years": null, "children": 93191, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "NCT02047981 posted results, adverse events module (all-cause deaths by group; no time frame stated)" } ], "deaths_ascertainment": "Biannual census of the communities: census periods started in December 2014, August 2015, February 2016, August 2016 and February 2017, data collection completed by July 2017; 323,302 person-years monitored over the 5 census visits (111,559 Malawi, 145,597 Niger, 66,146 Tanzania). A subset of households was re-censused by an independent team: 95% (257/271) Malawi, 92% (286/310) Niger and 95% (4544/4791) Tanzania of re-censused children had been enumerated on the first census. No randomization units were lost to follow-up after the initial census; the proportion of children recorded as moved or unknown did not differ significantly between arms (P=0.71 and P=0.36) (pmid:29694816). A death is a child reported alive at one census and deceased at the next; in Niger the verbal autopsy confirmed the census death for 3301 (98·9%) of 3339 cases, and 22 (1·3%) of 1727 azithromycin and 11 (0·6%) of 1888 placebo census deaths were found alive (pmid:31981558). Malawi: verbal autopsies completed for 1,131 of 1,184 deaths (pmid:32342837). Niger children 1-11 months with weight: 5,189 children lost to follow-up over the 2-year study period, a similar percentage in each arm (pmid:32931496). MORDOR II (Niger, year 3): census periods February 2017 to August 2017, September 2017 to January 2018 and February 2018 to August 2018; no communities lost to follow-up; census status moved or unknown in 4079 of 64,225 cases (6.4%) in communities receiving their first year of azithromycin and 4685 of 72,108 (6.5%) in those receiving their third year (p=0.48) (pmid:31167050). Registry: deaths assessed via biannual population census (Niger), a census at 6-monthly intervals (Tanzania) (NCT02047981). In a 16-community substudy of the Niger census, 10.9% of children had unknown vital status at any time during the 5-year census period (pmid:37903434).", "coverage": "Coverage of the targeted population of children: 90.3% (±10.6%) azithromycin, 90.4% (standard deviation 10.1%) placebo; Malawi 91.5% (±6.1%) azithromycin, 91.5% (±6.4%) placebo; Niger 94.5% (±6.0%) azithromycin, 94.5% (±6.7%) placebo; Tanzania 85.5% (±13.6%) azithromycin, 86.1% (±12.3%) placebo (pmid:29694816). Niger: mean coverage 90·3% (SD 10·6) azithromycin, 90·4% (10·1) placebo across the four distributions (pmid:31981558); greater than 91% over the 4 inter-census periods in both arms among children 1-59 months (pmid:32931496); mean treatment coverage of 90% (SD 10%) in both arms (pmid:34508582). Tanzania: 89.9±14.1% azithromycin vs 90.5±12.7% placebo (pmid:34559801). MORDOR II (Niger year 3, both arms given azithromycin): 92.0% (±6.6%) in the original azithromycin communities, 91.3% (±7.2%) in the original placebo communities (pmid:31167050). Niger infants 1-5 months in the caregiver safety survey: 70.2% (N = 1,201) received study treatment, no difference between arms (P = 0.22) (pmid:30419040).", "notes": "Countries of the secondary reports: pmid:31167050 (MORDOR II), pmid:31981558, pmid:38100110, pmid:32931496 and pmid:34508582 cover the 594 Niger communities (303 azithromycin, 291 placebo, as in pmid:29694816 Table 1); the registry calls the 36-month outcome a contingency study in Niger only, and its numbers match pmid:31167050's year 3. pmid:34559801 covers Tanzania (its Fig 1 names Tanzania). pmid:32342837 and pmid:32342840 cover Malawi. The same estimate is printed with different numbers: Niger 18.1% lower (10.0%-25.5%) in pmid:29694816, IRR 0.82 (0.74, 0.90) in pmid:34508582's Background and HR 0.81 (.75-.87) in pmid:30561577; Malawi 5.7% lower (-9.7%-18.9%), rate ratio 0.91 (0.79-1.05) in pmid:32342837 and HR 0.96 (.84-1.14); Tanzania 3.4% lower (-21.2%-23.0%) and HR 0.996 (.80-1.24). The Malawi placebo rate is 9.6 in pmid:29694816 and 9.26 in pmid:32342840 Table 4. Coverage for Niger is 94.5% in pmid:29694816 but 90·3%/90·4% in pmid:31981558 (the values pmid:29694816 gives for all countries), and for Tanzania 85.5%/86.1% in pmid:29694816 but 89.9%/90.5% in pmid:34559801. Verbal autopsy totals (pmid:31981558 Table 3 'Total', IRR 0.82 (0.75-0.90) on 1566 and 1735 deaths, and the registry's Niger verbal autopsy 'Total', 22.3 vs 27.3) count only deaths whose cause the verbal autopsy ascertained, not all 1727 and 1888 census deaths. MORDOR II extension (Niger, year 3): both arms were given azithromycin; 'treated' is the communities first randomized to azithromycin (their third year of azithromycin) and 'control' those first randomized to placebo (their first year). Table 2 prints 3.5% (-8.3%-14%) as the 'Difference between arms'; the text calls it 'a relative 3.5% ... more deaths in those communities randomized to the first year of treatment', so it is coded as a percent reduction in the original azithromycin arm, like years 1 and 2 in the same column. The within-arm comparisons of MORDOR I with MORDOR II (13.3%, -3.6%, -13.0%, 2.1%) are not between-arm estimates and were not extracted. pmid:29694816 prints the placebo arm's rate but not the azithromycin arm's; its children are baseline census counts (Table 1). It does not say how the country, age and period estimates were analysed (only the overall one is called community-level). Of the age bands and inter-census periods it prints only the 1-5 month band and the first and last periods; the rest are in Figures 3-4 without printed numbers. Its total person-years are not given per arm. NCT02047981: the 24-month primary outcome posts rates (14.6 vs 16.5) with no dispersion and no ratio, ages printed as 1-60 months; the adverse events module (3262 of 97047 vs 3392 of 93191 deaths) gives no time frame. Malawi counts differ between reports: 152 and 152 communities with 39,386 and 39,534 children (pmid:29694816 Table 1), 167 and 167 clusters with 43,105 and 42,825 children enrolled (pmid:32342840 Table 2), and 334 randomization units (pmid:32342837). pmid:32342840 Table 4 prints person-years in thousands (copied as strings with that unit), does not state its period, and gives rate differences, not ratios: Monkey Bay 0.33, Chilipa 0.65, Makanjira −0.50, Namwera 2.91, Mangochi −0.57, Total 0.82 deaths per 1,000 person-years (a negative difference means higher mortality with azithromycin). pmid:32342837 does not state the method of its all-cause rate ratio (its cause-specific Tables 4-5 use a random-effects Poisson model adjusting for clustering); the person-years per arm in that entry are the denominators of Table 4. All-cause deaths per arm are not printed there (1,184 in total; 597 placebo and 534 azithromycin deaths with a verbal autopsy). pmid:34559801 (Tanzania) prints rates per 100 person-years (copied as strings with that unit) and beside each IRR the reduction in mortality: 1-5 months 20% (-39% to 54%), 6-11 months 8% (-48% to 43%), 12-23 months -3% (-48% to 38%), 24-59 months -5% (-50% to 26%); the IRR was taken as the estimate. For all ages it gives deaths and person-years but no ratio ('not significant after adjusting for community clustering'), and median (IQR) community-level rates of 0.0 (0.00, 0.99) azithromycin and 0.0 (0.0, 1.03) placebo per 100 person-years (p = 0.51), which have no field and were not made an entry. pmid:32931496 (Niger) is restricted to 27,222 children 1-11 months with a valid weight at entry (12,086 excluded); Table 2 also prints rate differences (overall −12.6, −18.5 to −6.9). Its Table 3 hazard ratios are a Cox sensitivity analysis; the text gives them as 27% lower (95% CI 15–38) for WAZ ≥ −2, 30% lower (11–45) for WAZ < −2 and 38% lower (14–55) for WAZ < −3. pmid:38100110 gives model-based IRRs at 0, 1, 5 and 10 km from the nearest primary health center, adjusted for community mean age; the text gives the same as reductions of 0% (−19% to 17%), 4% (−12% to 17%), 16% (7%-23%) and 28% (17%-38%). pmid:34508582 is an abstract: its treated-children (complier average causal effect) and untreated-children (spillover) IRRs rest on 2581 and 245 deaths in total, not given per arm. pmid:30561577 prints hazard ratios by country only (log-rank P = .004 overall, no all-country ratio)." }, { "trial": "T02", "entries": [ { "comparison": "Azithro vs Placebo", "ages": "1-60 months", "period": "whole", "subgroup": null, "estimate": null, "treated": { "deaths": null, "person_years": null, "children": 33173, "rate_per_1000_person_years": 24.8, "rate_lower": 23.1, "rate_upper": 26.5 }, "control": { "deaths": null, "person_years": null, "children": 33055, "rate_per_1000_person_years": 26.7, "rate_lower": 24.5, "rate_upper": 28.5 }, "adjusted_for_clustering": null, "primary": true, "where": "NCT03338244 posted results, primary outcome 'All-cause Mortality Rate in Children Aged 1-60 Months', time frame 24 months" }, { "comparison": "Azithro vs Placebo", "ages": "1-60 months", "period": "whole", "subgroup": null, "estimate": null, "treated": { "deaths": 1493, "person_years": null, "children": 33173, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 1584, "person_years": null, "children": 33055, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "NCT03338244 posted results, adverse events module (all-cause deaths by group; no time frame stated)" } ], "deaths_ascertainment": "Deaths counted 'by presence on census and absence on sequential census due to death' (NCT03338244, primary outcome description); no numbers lost to follow-up are printed.", "coverage": null, "notes": "The only source is the ClinicalTrials.gov record NCT03338244: the primary outcome posts rates with 95% CIs per arm but no ratio, ages printed as 1-60 months, and its population is described as 'Number of participants at the start of MORDOR III'. The adverse events module (1493 of 33173 vs 1584 of 33055 deaths) gives no time frame; its denominators are the primary outcome's. No coverage is printed." }, { "trial": "T03", "entries": [ { "comparison": "Azithro 1-59 vs Placebo", "ages": "1-59 months", "period": "whole", "subgroup": null, "estimate": { "measure": "percent reduction", "value": 14, "lower": 7, "upper": 22, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 11.9, "rate_lower": 11.3, "rate_upper": 12.6 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 13.9, "rate_lower": 13.0, "rate_upper": 14.8 }, "adjusted_for_clustering": true, "primary": true, "where": "pmid:39167806 abstract, Results (one of three primary community-level mortality outcomes)" }, { "comparison": "Azithro 1-59 vs Placebo", "ages": "1-11 months", "period": "whole", "subgroup": null, "estimate": { "measure": "percent reduction", "value": 23, "lower": 11, "upper": 33, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 18.5, "rate_lower": 16.7, "rate_upper": 20.4 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 23.9, "rate_lower": 21.6, "rate_upper": 26.2 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40638118 Results text (rates by arm; 'overall reduction in mortality at 1 to 11 months of age in communities receiving any azithromycin compared with placebo')" }, { "comparison": "Azithro 1-59 vs Placebo", "ages": "1-11 months", "period": "whole", "subgroup": "children 1-11 months weighed in at least one round (WAZ analysis population)", "estimate": null, "treated": { "deaths": 334, "person_years": 18413, "children": null, "rate_per_1000_person_years": 18.1, "rate_lower": 15.9, "rate_upper": 20.1 }, "control": { "deaths": 374, "person_years": 15603, "children": null, "rate_per_1000_person_years": 24.0, "rate_lower": 21.4, "rate_upper": 26.6 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40147984 Table 2, Overall row" }, { "comparison": "Azithro 1-59 vs Placebo", "ages": "1-11 months", "period": "whole", "subgroup": "WAZ ≥−2", "estimate": null, "treated": { "deaths": 211, "person_years": 13909, "children": null, "rate_per_1000_person_years": 15.2, "rate_lower": 13.1, "rate_upper": 17.2 }, "control": { "deaths": 242, "person_years": 11821, "children": null, "rate_per_1000_person_years": 20.5, "rate_lower": 18.4, "rate_upper": 23.5 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40147984 Table 2 (WAZ category, moderate to severe)" }, { "comparison": "Azithro 1-59 vs Placebo", "ages": "1-11 months", "period": "whole", "subgroup": "WAZ <−2 (moderate to severe underweight)", "estimate": { "measure": "percent reduction", "value": 23, "lower": 1, "upper": 41, "level": 0.95 }, "treated": { "deaths": 123, "person_years": 4504, "children": null, "rate_per_1000_person_years": 27.3, "rate_lower": 21.8, "rate_upper": 32.2 }, "control": { "deaths": 132, "person_years": 3781, "children": null, "rate_per_1000_person_years": 34.9, "rate_lower": 29.3, "rate_upper": 40.9 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40147984 Table 2 (WAZ category, moderate to severe) and Results text (reduction in mortality)" }, { "comparison": "Azithro 1-59 vs Placebo", "ages": "1-11 months", "period": "whole", "subgroup": "WAZ ≥−3", "estimate": null, "treated": { "deaths": 268, "person_years": 16610, "children": null, "rate_per_1000_person_years": 16.1, "rate_lower": 13.9, "rate_upper": 18.1 }, "control": { "deaths": 305, "person_years": 14150, "children": null, "rate_per_1000_person_years": 21.6, "rate_lower": 19.5, "rate_upper": 24.2 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40147984 Table 2 (WAZ category, severe)" }, { "comparison": "Azithro 1-59 vs Placebo", "ages": "1-11 months", "period": "whole", "subgroup": "WAZ <−3 (severe underweight)", "estimate": { "measure": "percent reduction", "value": 24, "lower": -5, "upper": 47, "level": 0.95 }, "treated": { "deaths": 66, "person_years": 1803, "children": null, "rate_per_1000_person_years": 36.6, "rate_lower": 26.9, "rate_upper": 44.7 }, "control": { "deaths": 69, "person_years": 1453, "children": null, "rate_per_1000_person_years": 47.5, "rate_lower": 37.1, "rate_upper": 58.4 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40147984 Table 2 (WAZ category, severe) and Results text (reduction in mortality)" }, { "comparison": "Azithro 1-59 vs Placebo", "ages": "1-59 months", "period": "whole", "subgroup": null, "estimate": null, "treated": { "deaths": null, "person_years": null, "children": 153626, "rate_per_1000_person_years": 11.9, "rate_lower": 11.3, "rate_upper": 12.6 }, "control": { "deaths": null, "person_years": null, "children": 124617, "rate_per_1000_person_years": 13.9, "rate_lower": 13.0, "rate_upper": 14.8 }, "adjusted_for_clustering": null, "primary": true, "where": "NCT04224987 posted results, primary outcome 'All-cause Mortality (1-59 Months Old)', time frame from 6 months up to 2.5 years" }, { "comparison": "Azithro 1-59 vs Placebo", "ages": "1-11 months", "period": "whole", "subgroup": null, "estimate": null, "treated": { "deaths": null, "person_years": null, "children": 38506, "rate_per_1000_person_years": 18.5, "rate_lower": 16.7, "rate_upper": 20.4 }, "control": { "deaths": null, "person_years": null, "children": 32218, "rate_per_1000_person_years": 23.9, "rate_lower": 21.6, "rate_upper": 26.2 }, "adjusted_for_clustering": null, "primary": false, "where": "NCT04224987 posted results, primary outcome 'All-cause Mortality (1-11 Months Old)', time frame from 6 months up to 2.5 years" }, { "comparison": "Azithro 1-59 vs Placebo", "ages": "12-59 months", "period": "whole", "subgroup": null, "estimate": null, "treated": { "deaths": null, "person_years": null, "children": 115120, "rate_per_1000_person_years": 10.7, "rate_lower": 10.0, "rate_upper": 11.4 }, "control": { "deaths": null, "person_years": null, "children": 92399, "rate_per_1000_person_years": 12.0, "rate_lower": 11.2, "rate_upper": 13.0 }, "adjusted_for_clustering": null, "primary": false, "where": "NCT04224987 posted results, primary outcome 'All-cause Mortality (12-59 Months Old)', time frame from 6 months up to 2.5 years" }, { "comparison": "Azithro 1-59 vs Placebo", "ages": "1-11 months", "period": "whole", "subgroup": "children 1-11 months with a recorded weight and a valid WAZ (WAZ analysis population)", "estimate": null, "treated": { "deaths": null, "person_years": null, "children": 37943, "rate_per_1000_person_years": 18.1, "rate_lower": 15.9, "rate_upper": 20.1 }, "control": { "deaths": null, "person_years": null, "children": 31781, "rate_per_1000_person_years": 24, "rate_lower": 21.4, "rate_upper": 26.6 }, "adjusted_for_clustering": null, "primary": false, "where": "NCT04224987 posted results, secondary outcome 'Mortality Rate by Weight-for-age Z-score Subgroup Among Infants Aged 1-11 Months' (overall rate of the analysis population), time frame after 4 distributions" }, { "comparison": "Azithro 1-59 vs Placebo", "ages": "1-59 months", "period": "whole", "subgroup": null, "estimate": null, "treated": { "deaths": 1914, "person_years": null, "children": 153626, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 1923, "person_years": null, "children": 124617, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "NCT04224987 posted results, adverse events module (all-cause deaths by group; no time frame stated)" }, { "comparison": "Azithro 1-11 vs Placebo", "ages": "1-11 months", "period": "whole", "subgroup": null, "estimate": { "measure": "percent reduction", "value": 6, "lower": -8, "upper": 19, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 22.3, "rate_lower": 20.0, "rate_upper": 24.7 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 23.9, "rate_lower": 21.6, "rate_upper": 26.2 }, "adjusted_for_clustering": true, "primary": true, "where": "pmid:39167806 abstract, Results (one of three primary community-level mortality outcomes)" }, { "comparison": "Azithro 1-11 vs Placebo", "ages": "1-11 months", "period": "whole", "subgroup": null, "estimate": null, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 22.3, "rate_lower": 20.0, "rate_upper": 24.7 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 23.9, "rate_lower": 21.6, "rate_upper": 26.2 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40638118 Results text (rates by arm)" }, { "comparison": "Azithro 1-11 vs Placebo", "ages": "1-11 months", "period": "whole", "subgroup": "older sibling aged 12-59 months in the household", "estimate": { "measure": "incidence rate ratio", "value": 0.96, "lower": 0.81, "upper": 1.14, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": true, "primary": false, "where": "pmid:40638118 Results text and Figure 3 (Poisson regression accounting for the adaptation and clustering)" }, { "comparison": "Azithro 1-11 vs Placebo", "ages": "1-11 months", "period": "whole", "subgroup": "no older sibling in the household", "estimate": { "measure": "incidence rate ratio", "value": 0.9, "lower": 0.71, "upper": 1.12, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": true, "primary": false, "where": "pmid:40638118 Results text and Figure 3 (Poisson regression accounting for the adaptation and clustering)" }, { "comparison": "Azithro 1-11 vs Placebo", "ages": "1-11 months", "period": "whole", "subgroup": "children 1-11 months weighed in at least one round (WAZ analysis population)", "estimate": null, "treated": { "deaths": 313, "person_years": 13935, "children": null, "rate_per_1000_person_years": 22.5, "rate_lower": 20.0, "rate_upper": 25.2 }, "control": { "deaths": 374, "person_years": 15603, "children": null, "rate_per_1000_person_years": 24.0, "rate_lower": 21.4, "rate_upper": 26.6 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40147984 Table 2, Overall row" }, { "comparison": "Azithro 1-11 vs Placebo", "ages": "1-11 months", "period": "whole", "subgroup": "WAZ ≥−2", "estimate": null, "treated": { "deaths": 212, "person_years": 10660, "children": null, "rate_per_1000_person_years": 19.9, "rate_lower": 17.3, "rate_upper": 23.0 }, "control": { "deaths": 242, "person_years": 11821, "children": null, "rate_per_1000_person_years": 20.5, "rate_lower": 18.4, "rate_upper": 23.5 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40147984 Table 2 (WAZ category, moderate to severe)" }, { "comparison": "Azithro 1-11 vs Placebo", "ages": "1-11 months", "period": "whole", "subgroup": "WAZ <−2 (moderate to severe underweight)", "estimate": { "measure": "percent reduction", "value": 11, "lower": -11, "upper": 32, "level": 0.95 }, "treated": { "deaths": 101, "person_years": 3275, "children": null, "rate_per_1000_person_years": 30.8, "rate_lower": 25.2, "rate_upper": 36.5 }, "control": { "deaths": 132, "person_years": 3781, "children": null, "rate_per_1000_person_years": 34.9, "rate_lower": 29.3, "rate_upper": 40.9 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40147984 Table 2 (WAZ category, moderate to severe) and Results text (reduction in mortality)" }, { "comparison": "Azithro 1-11 vs Placebo", "ages": "1-11 months", "period": "whole", "subgroup": "WAZ ≥−3", "estimate": null, "treated": { "deaths": 269, "person_years": 12726, "children": null, "rate_per_1000_person_years": 21.2, "rate_lower": 18.8, "rate_upper": 23.9 }, "control": { "deaths": 305, "person_years": 14150, "children": null, "rate_per_1000_person_years": 21.6, "rate_lower": 19.5, "rate_upper": 24.2 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40147984 Table 2 (WAZ category, severe)" }, { "comparison": "Azithro 1-11 vs Placebo", "ages": "1-11 months", "period": "whole", "subgroup": "WAZ <−3 (severe underweight)", "estimate": { "measure": "percent reduction", "value": 23, "lower": -11, "upper": 47, "level": 0.95 }, "treated": { "deaths": 44, "person_years": 1209, "children": null, "rate_per_1000_person_years": 36.4, "rate_lower": 26.8, "rate_upper": 46.4 }, "control": { "deaths": 69, "person_years": 1453, "children": null, "rate_per_1000_person_years": 47.5, "rate_lower": 37.1, "rate_upper": 58.4 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40147984 Table 2 (WAZ category, severe) and Results text (reduction in mortality)" }, { "comparison": "Azithro 1-11 vs Placebo", "ages": "1-59 months", "period": "whole", "subgroup": null, "estimate": null, "treated": { "deaths": null, "person_years": null, "children": 104374, "rate_per_1000_person_years": 13.8, "rate_lower": 12.9, "rate_upper": 14.8 }, "control": { "deaths": null, "person_years": null, "children": 124617, "rate_per_1000_person_years": 13.9, "rate_lower": 13.0, "rate_upper": 14.8 }, "adjusted_for_clustering": null, "primary": false, "where": "NCT04224987 posted results, primary outcome 'All-cause Mortality (1-59 Months Old)', time frame from 6 months up to 2.5 years" }, { "comparison": "Azithro 1-11 vs Placebo", "ages": "1-11 months", "period": "whole", "subgroup": null, "estimate": null, "treated": { "deaths": null, "person_years": null, "children": 38573, "rate_per_1000_person_years": 22.3, "rate_lower": 10.0, "rate_upper": 24.7 }, "control": { "deaths": null, "person_years": null, "children": 32218, "rate_per_1000_person_years": 23.9, "rate_lower": 21.6, "rate_upper": 26.2 }, "adjusted_for_clustering": null, "primary": true, "where": "NCT04224987 posted results, primary outcome 'All-cause Mortality (1-11 Months Old)', time frame from 6 months up to 2.5 years" }, { "comparison": "Azithro 1-11 vs Placebo", "ages": "12-59 months", "period": "whole", "subgroup": null, "estimate": null, "treated": { "deaths": null, "person_years": null, "children": 65801, "rate_per_1000_person_years": 12.2, "rate_lower": 11.3, "rate_upper": 13.1 }, "control": { "deaths": null, "person_years": null, "children": 92399, "rate_per_1000_person_years": 12.0, "rate_lower": 11.2, "rate_upper": 13.0 }, "adjusted_for_clustering": null, "primary": false, "where": "NCT04224987 posted results, primary outcome 'All-cause Mortality (12-59 Months Old)', time frame from 6 months up to 2.5 years" }, { "comparison": "Azithro 1-11 vs Placebo", "ages": "1-11 months", "period": "whole", "subgroup": "children 1-11 months with a recorded weight and a valid WAZ (WAZ analysis population)", "estimate": null, "treated": { "deaths": null, "person_years": null, "children": 27842, "rate_per_1000_person_years": 22.5, "rate_lower": 20, "rate_upper": 25.2 }, "control": { "deaths": null, "person_years": null, "children": 31781, "rate_per_1000_person_years": 24, "rate_lower": 21.4, "rate_upper": 26.6 }, "adjusted_for_clustering": null, "primary": false, "where": "NCT04224987 posted results, secondary outcome 'Mortality Rate by Weight-for-age Z-score Subgroup Among Infants Aged 1-11 Months' (overall rate of the analysis population), time frame after 4 distributions" }, { "comparison": "Azithro 1-11 vs Placebo", "ages": "1-59 months", "period": "whole", "subgroup": null, "estimate": null, "treated": { "deaths": 1666, "person_years": null, "children": 104374, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 1923, "person_years": null, "children": 124617, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "NCT04224987 posted results, adverse events module (all-cause deaths by group; no time frame stated)" }, { "comparison": "Azithro 1-59 vs Azithro 1-11", "ages": "1-11 months", "period": "whole", "subgroup": null, "estimate": null, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 18.5, "rate_lower": 16.7, "rate_upper": 20.4 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 22.3, "rate_lower": 20.0, "rate_upper": 24.7 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40638118 Results text (rates by arm)" }, { "comparison": "Azithro 1-59 vs Azithro 1-11", "ages": "1-11 months", "period": "whole", "subgroup": "older sibling aged 12-59 months in the household", "estimate": { "measure": "incidence rate ratio", "value": 0.78, "lower": 0.65, "upper": 0.93, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": true, "primary": false, "where": "pmid:40638118 Results text and Figure 2 (Poisson regression accounting for the adaptation and clustering)" }, { "comparison": "Azithro 1-59 vs Azithro 1-11", "ages": "1-11 months", "period": "whole", "subgroup": "no older sibling in the household", "estimate": { "measure": "incidence rate ratio", "value": 0.91, "lower": 0.73, "upper": 1.15, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": true, "primary": false, "where": "pmid:40638118 Results text and Figure 2 (Poisson regression accounting for the adaptation and clustering)" }, { "comparison": "Azithro 1-59 vs Azithro 1-11", "ages": "1-11 months", "period": "whole", "subgroup": "children 1-11 months weighed in at least one round (WAZ analysis population)", "estimate": null, "treated": { "deaths": 334, "person_years": 18413, "children": null, "rate_per_1000_person_years": 18.1, "rate_lower": 15.9, "rate_upper": 20.1 }, "control": { "deaths": 313, "person_years": 13935, "children": null, "rate_per_1000_person_years": 22.5, "rate_lower": 20.0, "rate_upper": 25.2 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40147984 Table 2, Overall row" }, { "comparison": "Azithro 1-59 vs Azithro 1-11", "ages": "1-11 months", "period": "whole", "subgroup": "WAZ ≥−2", "estimate": null, "treated": { "deaths": 211, "person_years": 13909, "children": null, "rate_per_1000_person_years": 15.2, "rate_lower": 13.1, "rate_upper": 17.2 }, "control": { "deaths": 212, "person_years": 10660, "children": null, "rate_per_1000_person_years": 19.9, "rate_lower": 17.3, "rate_upper": 23.0 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40147984 Table 2 (WAZ category, moderate to severe)" }, { "comparison": "Azithro 1-59 vs Azithro 1-11", "ages": "1-11 months", "period": "whole", "subgroup": "WAZ <−2 (moderate to severe underweight)", "estimate": null, "treated": { "deaths": 123, "person_years": 4504, "children": null, "rate_per_1000_person_years": 27.3, "rate_lower": 21.8, "rate_upper": 32.2 }, "control": { "deaths": 101, "person_years": 3275, "children": null, "rate_per_1000_person_years": 30.8, "rate_lower": 25.2, "rate_upper": 36.5 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40147984 Table 2 (WAZ category, moderate to severe)" }, { "comparison": "Azithro 1-59 vs Azithro 1-11", "ages": "1-11 months", "period": "whole", "subgroup": "WAZ ≥−3", "estimate": null, "treated": { "deaths": 268, "person_years": 16610, "children": null, "rate_per_1000_person_years": 16.1, "rate_lower": 13.9, "rate_upper": 18.1 }, "control": { "deaths": 269, "person_years": 12726, "children": null, "rate_per_1000_person_years": 21.2, "rate_lower": 18.8, "rate_upper": 23.9 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40147984 Table 2 (WAZ category, severe)" }, { "comparison": "Azithro 1-59 vs Azithro 1-11", "ages": "1-11 months", "period": "whole", "subgroup": "WAZ <−3 (severe underweight)", "estimate": null, "treated": { "deaths": 66, "person_years": 1803, "children": null, "rate_per_1000_person_years": 36.6, "rate_lower": 26.9, "rate_upper": 44.7 }, "control": { "deaths": 44, "person_years": 1209, "children": null, "rate_per_1000_person_years": 36.4, "rate_lower": 26.8, "rate_upper": 46.4 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40147984 Table 2 (WAZ category, severe)" }, { "comparison": "Azithro 1-59 vs Azithro 1-11", "ages": "1-59 months", "period": "whole", "subgroup": null, "estimate": null, "treated": { "deaths": null, "person_years": null, "children": 153626, "rate_per_1000_person_years": 11.9, "rate_lower": 11.3, "rate_upper": 12.6 }, "control": { "deaths": null, "person_years": null, "children": 104374, "rate_per_1000_person_years": 13.8, "rate_lower": 12.9, "rate_upper": 14.8 }, "adjusted_for_clustering": null, "primary": false, "where": "NCT04224987 posted results, primary outcome 'All-cause Mortality (1-59 Months Old)', time frame from 6 months up to 2.5 years" }, { "comparison": "Azithro 1-59 vs Azithro 1-11", "ages": "1-11 months", "period": "whole", "subgroup": null, "estimate": null, "treated": { "deaths": null, "person_years": null, "children": 38506, "rate_per_1000_person_years": 18.5, "rate_lower": 16.7, "rate_upper": 20.4 }, "control": { "deaths": null, "person_years": null, "children": 38573, "rate_per_1000_person_years": 22.3, "rate_lower": 10.0, "rate_upper": 24.7 }, "adjusted_for_clustering": null, "primary": false, "where": "NCT04224987 posted results, primary outcome 'All-cause Mortality (1-11 Months Old)', time frame from 6 months up to 2.5 years" }, { "comparison": "Azithro 1-59 vs Azithro 1-11", "ages": "12-59 months", "period": "whole", "subgroup": null, "estimate": null, "treated": { "deaths": null, "person_years": null, "children": 115120, "rate_per_1000_person_years": 10.7, "rate_lower": 10.0, "rate_upper": 11.4 }, "control": { "deaths": null, "person_years": null, "children": 65801, "rate_per_1000_person_years": 12.2, "rate_lower": 11.3, "rate_upper": 13.1 }, "adjusted_for_clustering": null, "primary": true, "where": "NCT04224987 posted results, primary outcome 'All-cause Mortality (12-59 Months Old)', time frame from 6 months up to 2.5 years" }, { "comparison": "Azithro 1-59 vs Azithro 1-11", "ages": "1-11 months", "period": "whole", "subgroup": "children 1-11 months with a recorded weight and a valid WAZ (WAZ analysis population)", "estimate": null, "treated": { "deaths": null, "person_years": null, "children": 37943, "rate_per_1000_person_years": 18.1, "rate_lower": 15.9, "rate_upper": 20.1 }, "control": { "deaths": null, "person_years": null, "children": 27842, "rate_per_1000_person_years": 22.5, "rate_lower": 20, "rate_upper": 25.2 }, "adjusted_for_clustering": null, "primary": false, "where": "NCT04224987 posted results, secondary outcome 'Mortality Rate by Weight-for-age Z-score Subgroup Among Infants Aged 1-11 Months' (overall rate of the analysis population), time frame after 4 distributions" }, { "comparison": "Azithro 1-59 vs Azithro 1-11", "ages": "1-59 months", "period": "whole", "subgroup": null, "estimate": null, "treated": { "deaths": 1914, "person_years": null, "children": 153626, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 1666, "person_years": null, "children": 104374, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "NCT04224987 posted results, adverse events module (all-cause deaths by group; no time frame stated)" } ], "deaths_ascertainment": "Census workers who were not aware of the group assignments monitored mortality twice yearly over the course of 2 years (pmid:39167806). Dynamic cohort: communities and children could enter, leave and re-enter in the different intercensus intervals; enrollment began November 24, 2020, 5 MDAs about every 6 months, follow-up completed July 31, 2023; no communities were lost to follow-up (pmid:40638118). Communities analysed: 1229 of 1273 child azithromycin, 751 of 773 infant azithromycin, 929 of 954 placebo (pmid:39167806); 117 communities excluded after randomization (39 census inaccuracies, 7 refusals, 40 insecure areas, 2 moved communities, 2 protocol deviations, 1 with only 1 census household, 26 with no person-time for infants) (pmid:40638118 Figure 1). No number of children lost to follow-up is printed.", "coverage": "Mean (SD) treatment coverage across MDAs was 97.1% (5.5%) (pmid:40638118, eTable 1); coverage is not printed per arm.", "notes": "The main report is available only as an abstract; its third primary outcome (children 12-59 months, Azithro 1-59 vs Azithro 1-11) has no printed numbers there, and the registry posts rates for it without a ratio. The registry posts each primary outcome's rates for all three arms; its descriptions name the primary comparison (1-59 months: azithro 1-59 vs placebo; 1-11 months: azithro 1-11 vs placebo; 12-59 months: azithro 1-11 vs azithro 1-59), so the other pairwise entries from the same outcome are marked not primary. In the Azithro 1-11 arm children 12-59 months received placebo, so its 12-59-month entries compare children not given azithromycin. The registry prints the Azithro 1-11 arm's 1-11-month rate as 22.3 [10.0, 24.7]; pmid:39167806 and pmid:40638118 print 22.3 (20.0 to 24.7). pmid:40638118's 23% (11%-33%) is described as 'communities receiving any azithromycin compared with placebo', 23.5% (1.2%-72.7%) of it 'explained by treating infants' and 76.5% (27.3%-98.8%) 'by also treating children 12 to 59 months of age', so it was coded as Azithro 1-59 vs Placebo; it prints no ratio for the infant arm vs placebo or the child arm vs the infant arm overall, only rates. It also prints incidence rate differences by sibling (child vs infant −4.94 and −1.90; infant vs placebo −0.90 and −2.56), not extracted, and gives 1432 deaths and 69 590 person-years in total, not per arm. pmid:40147984's Overall row is the WAZ analysis population ('Results will differ slightly from the main trial results since this subgroup analysis uses a different subpopulation'); it prints percent reductions only for the underweight subgroups (WAZ <−2 and <−3) and rate differences (8.0, 11.2, 4.0, 10.9 fewer deaths per 1000 person-years; Dosso 18.6 and 12.2); its Azithro 1-59 vs Azithro 1-11 entries are the two arms' printed rows, not a comparison the paper makes. The adverse events module's denominators are the 1-59-month primary outcome's; it gives no time frame. pmid:39167806 gives 382,586 children, 419,440 person-years and 5503 deaths in total, not per arm." }, { "trial": "T07", "entries": [ { "comparison": "Azithromycin-biannually vs Control", "ages": "1-11 months", "period": "whole", "subgroup": null, "estimate": { "measure": "incidence rate ratio", "value": 1.0, "lower": 0.83, "upper": 1.19, "level": 0.95 }, "treated": { "deaths": 437, "person_years": 37072.0, "children": 18040, "rate_per_1000_person_years": 11.8, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 335, "person_years": 28117.9, "children": 13187, "rate_per_1000_person_years": 11.9, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": true, "where": "pmid:41092331 Table 2 and Results (Primary Outcomes); IRR adjusted for the stratified randomization factor (village size category); children are infants 1-11 months at the first MDA (Table 1)" }, { "comparison": "Azithromycin-biannually vs Control", "ages": "12-59 months", "period": "whole", "subgroup": null, "estimate": { "measure": "incidence rate ratio", "value": 1.03, "lower": 0.85, "upper": 1.24, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:41092331 Results (Secondary Outcomes; Table S5 cited, not in sources)" }, { "comparison": "Azithromycin-quarterly vs Control", "ages": "1-11 months", "period": "whole", "subgroup": null, "estimate": { "measure": "incidence rate ratio", "value": 0.93, "lower": 0.75, "upper": 1.15, "level": 0.95 }, "treated": { "deaths": 196, "person_years": 17409.5, "children": 8201, "rate_per_1000_person_years": 11.3, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 335, "person_years": 28117.9, "children": 13187, "rate_per_1000_person_years": 11.9, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": true, "where": "pmid:41092331 Table 2 and Results (Primary Outcomes); IRR adjusted for the stratified randomization factor (village size category); children are infants 1-11 months at the first MDA (Table 1)" }, { "comparison": "Azithromycin-quarterly vs Control", "ages": "12-59 months", "period": "whole", "subgroup": null, "estimate": { "measure": "incidence rate ratio", "value": 0.97, "lower": 0.77, "upper": 1.22, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:41092331 Results (Secondary Outcomes; Table S5 cited, not in sources)" }, { "comparison": "Azithromycin-quarterly vs Azithromycin-biannually", "ages": "1-11 months", "period": "whole", "subgroup": null, "estimate": { "measure": "incidence rate ratio", "value": 0.93, "lower": 0.76, "upper": 1.15, "level": 0.95 }, "treated": { "deaths": 196, "person_years": 17409.5, "children": 8201, "rate_per_1000_person_years": 11.3, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 437, "person_years": 37072.0, "children": 18040, "rate_per_1000_person_years": 11.8, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": true, "where": "pmid:41092331 Table 2 and Results (Primary Outcomes); IRR adjusted for the stratified randomization factor (village size category); children are infants 1-11 months at the first MDA (Table 1)" } ], "deaths_ascertainment": "Deaths recorded during the study among infants 1-11 months old at the time of MDA (968 deaths; 82,600 person-years at risk of follow-up overall), with 285,227 households registered (27 declined). Vital status was unknown for 4,080 (2.7%) treated infants due to migration or other loss to follow-up: 2.8% control, 2.7% biannual azithromycin, 2.6% quarterly azithromycin. The last MDA round in 128 villages was not completed due to study drug expiry, and follow-up was truncated for other reasons in 10 more villages. 967 deaths were recorded among untreated children 12-59 months old at the time of MDA (pmid:41092331).", "coverage": "Not printed per arm. Of the 9,085 planned MDA visits, 86.2% were completed on time, 1.0% early, 9.9% late and 2.9% missed, similar between arms; the study drug could not be given as planned at 10,094 (3.7%) of treatment visits, proportions similar across groups (Table S2); 149,201 infants received at least one dose, 274,896 recorded treatments (pmid:41092331).", "notes": "The IRRs are 'Adjusted for stratified randomization factor (village size category)'; the source does not say whether their intervals account for the randomization of villages. All three 1-11-month comparisons are reported under 'Primary Outcomes', so each is marked primary. Table 2 also prints incidence rate differences: biannual vs control −0.05 (−2.31 to 2.21), quarterly vs control −0.91 (−3.55 to 1.73), quarterly vs biannual −0.85 (−3.34 to 1.64). The 'children' counts are infants 1-11 months at the first MDA (Table 1: 13,187 control, 18,040 biannual, 8,201 quarterly), not all infants followed. The 12-59-month estimates are for children who were not treated; their deaths and person-years by arm are in Table S5, which is not in the sources, and no quarterly vs biannual estimate is printed for them. Age-specific rates for 12-59 months (10.6, 3.4, 2.2, 1.5) are for all arms together. Effect modification (age, sex, WAZ, SMC, assets, WASH, season, MDA order, distance, outreach, district) is reported without numbers in the sources (Fig. 2, Figs. S3-S5)." }, { "trial": "T08", "entries": [ { "comparison": "Biannual mass oral azithromycin + child health days vs Biannual mass placebo + child health days", "ages": "1-11 months", "period": "whole", "subgroup": null, "estimate": { "measure": "incidence rate ratio", "value": 1.04, "lower": 0.75, "upper": 1.46, "level": 0.95 }, "treated": { "deaths": 397, "person_years": 154051, "children": 201709, "rate_per_1000_person_years": 2.6, "rate_lower": 2.1, "rate_upper": 3.1 }, "control": { "deaths": 191, "person_years": 77364, "children": 100959, "rate_per_1000_person_years": 2.5, "rate_lower": 1.8, "rate_upper": 3.2 }, "adjusted_for_clustering": null, "primary": true, "where": "pmid:41506755 Results and Table 2 (birth history data, primary outcome)" }, { "comparison": "Biannual mass oral azithromycin + child health days vs Biannual mass placebo + child health days", "ages": "1-11 months", "period": "whole", "subgroup": null, "estimate": { "measure": "incidence rate ratio", "value": 0.98, "lower": 0.76, "upper": 1.26, "level": 0.95 }, "treated": { "deaths": 691, "person_years": 122519, "children": 167018, "rate_per_1000_person_years": 5.6, "rate_lower": 4.9, "rate_upper": 6.4 }, "control": { "deaths": 345, "person_years": 59710, "children": 80878, "rate_per_1000_person_years": 5.8, "rate_lower": 4.7, "rate_upper": 7.2 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:41506755 Results and Table 2 (census data, secondary outcome)" }, { "comparison": "Biannual mass oral azithromycin + child health days vs Biannual mass placebo + child health days", "ages": "1-11 months", "period": "whole", "subgroup": null, "estimate": { "measure": "incidence rate ratio", "value": 1.05, "lower": 0.77, "upper": 1.45, "level": 0.95 }, "treated": { "deaths": 496, "person_years": null, "children": 193248, "rate_per_1000_person_years": "3.3 per 1000 live births", "rate_lower": "2.7 per 1000 live births", "rate_upper": "3.9 per 1000 live births" }, "control": { "deaths": 247, "person_years": null, "children": 97205, "rate_per_1000_person_years": "3.1 per 1000 live births", "rate_lower": "2.3 per 1000 live births", "rate_upper": "3.9 per 1000 live births" }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:41506755 Results (secondary analysis of cumulative probability of mortality, synthetic cohort; children are live births; rates per 1000 live births)" } ], "deaths_ascertainment": "Primary outcome from birth histories collected during the last census of the study; 55 clusters could not be reached because of insecurity (38 azithromycin, 17 placebo). Secondary outcome from the census; 12 clusters were lost to follow-up because of insecurity and left out of the analysis (6 azithromycin, 6 placebo). 1265 verbal autopsies were conducted, 78% of the total 1624 deaths (pmid:41506755).", "coverage": "Treatment coverage was 58.4% in the first round and exceeded 90% in all other rounds (online supplemental table 2); not printed per arm (pmid:41506755).", "notes": "Birth history (primary) and census (secondary) give different deaths, person-years and rates for the same comparison; the Pearson correlation of their mortality rates was 0.45. The synthetic-cohort analysis reports deaths per 1000 live births (copied as strings with that unit), with the live births in 'children'; its age band is not stated (coded 1-11 months, the paper's outcome). The bias analysis for outcome misclassification gives only a rate difference (IRD 0.13, 95% uncertainty interval −0.34 to 0.62). The source does not say whether the intervals account for the randomization of clusters. Subgroup analyses by age group, sex, region and CSPS type are reported as showing no differences, without numbers (online supplemental table 3). Table 1 gives 64 647 azithromycin and 30 699 placebo children at the baseline census (332 and 168 CSPS)." }, { "trial": "T04", "entries": [ { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": null, "estimate": { "measure": "incidence rate ratio", "value": 0.82, "lower": 0.67, "upper": 1.02, "level": 0.95 }, "treated": { "deaths": 498, "person_years": 60592, "children": 34399, "rate_per_1000_person_years": 8.2, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 588, "person_years": 58547, "children": 33847, "rate_per_1000_person_years": 10.0, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": true, "where": "pmid:38349371 Results text (Figure 3): deaths, person-years, rates, IRR; ClinicalTrials.gov NCT03676764 primary outcome 'All-cause Mortality Rate in Children Aged 1-59 Months' (primary analysis included 34399 and 33847 children; rates 8.2 and 10.0) and adverse events module (deaths 498 of 34399, 588 of 33847); pmid:41252743 Results (the primary outcome, all-cause mortality, included 498 and 588 deaths)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": null, "estimate": { "measure": "incidence rate ratio", "value": 0.82, "lower": 0.66, "upper": 1.01, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": 34399, "rate_per_1000_person_years": 8.2, "rate_lower": 7.1, "rate_upper": 9.4 }, "control": { "deaths": null, "person_years": null, "children": 33847, "rate_per_1000_person_years": 10.0, "rate_lower": 8.4, "rate_upper": 11.7 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:41021553 Table 2 'Overall (Jan-Dec)' (rates, IRR) and Table 1 (number of children); same numbers in pmid:40343013 Tables 1 and 2" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-11 months", "period": "whole", "subgroup": null, "estimate": { "measure": "incidence rate ratio", "value": 0.99, "lower": 0.72, "upper": 1.36, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:38349371 Results text (prespecified subgroup by age group; Figure 3)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "12-23 months", "period": "whole", "subgroup": null, "estimate": { "measure": "incidence rate ratio", "value": 0.92, "lower": 0.67, "upper": 1.27, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:38349371 Results text (prespecified subgroup by age group; Figure 3)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "24-59 months", "period": "whole", "subgroup": null, "estimate": { "measure": "incidence rate ratio", "value": 0.73, "lower": 0.57, "upper": 0.94, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:38349371 Results text (prespecified subgroup by age group; Figure 3)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "year 1", "subgroup": null, "estimate": { "measure": "incidence rate ratio", "value": 0.76, "lower": 0.55, "upper": 1.04, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:38349371 Results text (prespecified subgroup by study year, first year; Figure 3)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "year 2", "subgroup": null, "estimate": { "measure": "incidence rate ratio", "value": 0.83, "lower": 0.62, "upper": 1.12, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:38349371 Results text (prespecified subgroup by study year, second year; Figure 3)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "year 3", "subgroup": null, "estimate": { "measure": "incidence rate ratio", "value": 0.87, "lower": 0.65, "upper": 1.18, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:38349371 Results text (prespecified subgroup by study year, third year; Figure 3)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Non-SMC season (Jan-Jun)", "estimate": { "measure": "incidence rate ratio", "value": 0.89, "lower": 0.68, "upper": 1.15, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 7.5, "rate_lower": 6.1, "rate_upper": 8.8 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 8.4, "rate_lower": 6.8, "rate_upper": 10.1 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:41021553 Table 2 'Non-SMC (Jan-Jun)' and Results text; same numbers in pmid:40343013 Table 2 and text, ppr:PPR1012955 abstract, and the coverage-adjusted sensitivity analysis in both versions (S3 Table; Supplementary Table 1)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "During/Post-SMC season (Jul-Dec)", "estimate": { "measure": "incidence rate ratio", "value": 0.77, "lower": 0.6, "upper": 0.98, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 9, "rate_lower": 7.5, "rate_upper": 10.4 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 11.7, "rate_lower": 9.5, "rate_upper": 13.9 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:41021553 Table 2 'During/Post-SMC (Jul-Dec)' and Results text; same numbers in pmid:40343013 Table 2 and text, ppr:PPR1012955 abstract, and the coverage-adjusted sensitivity analysis in both versions (S3 Table; Supplementary Table 1)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "During/Post-SMC months (Jul-Dec); all SMC coverage levels ('Overall' row of the SMC coverage-level analysis)", "estimate": { "measure": "incidence rate ratio", "value": 0.77, "lower": 0.6, "upper": 0.98, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 9.0, "rate_lower": 7.5, "rate_upper": 10.4 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 11.6, "rate_lower": 9.6, "rate_upper": 13.6 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40343013 Table 3 'Overall' row (Figure 5 note: analysis restricted to months during and after SMC distribution, July-December)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "During/Post-SMC months (Jul-Dec); SMC coverage 30% (model estimate at this coverage level)", "estimate": { "measure": "incidence rate ratio", "value": 0.57, "lower": 0.2, "upper": 0.95, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 8.5, "rate_lower": 4.8, "rate_upper": 12.3 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 14.9, "rate_lower": 7.6, "rate_upper": 22.2 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40343013 Table 3 '30%' row (Figure 5 note: restricted to July-December)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "During/Post-SMC months (Jul-Dec); SMC coverage 40% (model estimate at this coverage level)", "estimate": { "measure": "incidence rate ratio", "value": 0.62, "lower": 0.3, "upper": 0.94, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 8.6, "rate_lower": 5.7, "rate_upper": 11.6 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 13.9, "rate_lower": 8.6, "rate_upper": 19.2 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40343013 Table 3 '40%' row (Figure 5 note: restricted to July-December)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "During/Post-SMC months (Jul-Dec); SMC coverage 50% (model estimate at this coverage level)", "estimate": { "measure": "incidence rate ratio", "value": 0.68, "lower": 0.42, "upper": 0.93, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 8.8, "rate_lower": 6.6, "rate_upper": 11 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 12.9, "rate_lower": 9.3, "rate_upper": 16.5 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40343013 Table 3 '50%' row (Figure 5 note: restricted to July-December)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "During/Post-SMC months (Jul-Dec); SMC coverage 60% (model estimate at this coverage level)", "estimate": { "measure": "incidence rate ratio", "value": 0.74, "lower": 0.54, "upper": 0.93, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 8.9, "rate_lower": 7.3, "rate_upper": 10.5 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 12, "rate_lower": 9.7, "rate_upper": 14.4 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40343013 Table 3 '60%' row (Figure 5 note: restricted to July-December)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "During/Post-SMC months (Jul-Dec); SMC coverage 70% (model estimate at this coverage level)", "estimate": { "measure": "incidence rate ratio", "value": 0.8, "lower": 0.62, "upper": 0.99, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 9, "rate_lower": 7.5, "rate_upper": 10.5 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 11.2, "rate_lower": 9.4, "rate_upper": 13 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40343013 Table 3 '70%' row (Figure 5 note: restricted to July-December)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "During/Post-SMC months (Jul-Dec); SMC coverage 80% (model estimate at this coverage level)", "estimate": { "measure": "incidence rate ratio", "value": 0.88, "lower": 0.62, "upper": 1.14, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 9.2, "rate_lower": 7.2, "rate_upper": 11.1 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 10.5, "rate_lower": 8.3, "rate_upper": 12.6 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40343013 Table 3 '80%' row (Figure 5 note: restricted to July-December)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "During/Post-SMC months (Jul-Dec); SMC coverage 90% (model estimate at this coverage level)", "estimate": { "measure": "incidence rate ratio", "value": 0.95, "lower": 0.56, "upper": 1.35, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 9.3, "rate_lower": 6.5, "rate_upper": 12.1 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 9.7, "rate_lower": 6.9, "rate_upper": 12.6 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40343013 Table 3 '90%' row (Figure 5 note: restricted to July-December)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "During/Post-SMC months (Jul-Dec); SMC coverage 100% (model estimate at this coverage level)", "estimate": { "measure": "incidence rate ratio", "value": 1.04, "lower": 0.46, "upper": 1.62, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 9.4, "rate_lower": 5.7, "rate_upper": 13.2 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 9.1, "rate_lower": 5.5, "rate_upper": 12.6 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40343013 Table 3 '100%' row (Figure 5 note: restricted to July-December)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "All clusters in the 80% SMC coverage threshold analysis (N=285 clusters; months covered not stated)", "estimate": { "measure": "incidence rate ratio", "value": 0.78, "lower": 0.61, "upper": 0.99, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 9.0, "rate_lower": 7.5, "rate_upper": 10.4 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 11.5, "rate_lower": 9.4, "rate_upper": 13.6 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40343013 Table 4 'Across all clusters (N=285)'" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Clusters with SMC coverage below 80% (N=222 clusters; months covered not stated)", "estimate": { "measure": "incidence rate ratio", "value": 0.73, "lower": 0.56, "upper": 0.96, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 8.9, "rate_lower": 7.3, "rate_upper": 10.5 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 12.1, "rate_lower": 9.6, "rate_upper": 14.7 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40343013 Table 4 'Coverage below 80% (N=222)' and Results text; pmid:41021553 Results text (S1 and S2 Tables, not printed)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Clusters with SMC coverage 80% or above (N=86 clusters; months covered not stated)", "estimate": { "measure": "incidence rate ratio", "value": 1.0, "lower": 0.59, "upper": 1.69, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 9.2, "rate_lower": 5.9, "rate_upper": 12.6 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 9.2, "rate_lower": 5.8, "rate_upper": 12.7 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:40343013 Table 4 'Coverage 80% or above (N=86)' and Results text; pmid:41021553 Results text (S1 and S2 Tables, not printed)" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Children in households included in the pre-census (15,291 households in 170 clusters), across wealth quintiles; distance to facility as covariate", "estimate": { "measure": "incidence rate ratio", "value": 0.83, "lower": 0.63, "upper": 1.1, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 8.9, "rate_lower": 7.3, "rate_upper": 10.5 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 10.7, "rate_lower": 8.3, "rate_upper": 13.1 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:41662252 Table 4 'Across quintiles' (household level and cluster level, identical) and Results text; same numbers in pmid:40630579 Table 4 and text" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Household wealth index quintile 1st (least wealthy), pre-census households; distance to facility as covariate", "estimate": { "measure": "incidence rate ratio", "value": 0.88, "lower": 0.53, "upper": 1.24, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 11.5, "rate_lower": 8.6, "rate_upper": 14.3 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 13.0, "rate_lower": 8.8, "rate_upper": 17.1 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:41662252 Table 4, household level, quintile 1st; same in pmid:40630579 Table 4" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Household wealth index quintile 2nd, pre-census households; distance to facility as covariate", "estimate": { "measure": "incidence rate ratio", "value": 0.86, "lower": 0.58, "upper": 1.13, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 10.0, "rate_lower": 8.0, "rate_upper": 12.0 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 11.7, "rate_lower": 8.7, "rate_upper": 14.7 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:41662252 Table 4, household level, quintile 2nd; same in pmid:40630579 Table 4" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Household wealth index quintile 3rd, pre-census households; distance to facility as covariate", "estimate": { "measure": "incidence rate ratio", "value": 0.83, "lower": 0.59, "upper": 1.06, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 8.7, "rate_lower": 7.2, "rate_upper": 10.2 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 10.6, "rate_lower": 8.2, "rate_upper": 12.9 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:41662252 Table 4, household level, quintile 3rd; same in pmid:40630579 Table 4" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Household wealth index quintile 4th, pre-census households; distance to facility as covariate", "estimate": { "measure": "incidence rate ratio", "value": 0.8, "lower": 0.56, "upper": 1.04, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 7.6, "rate_lower": 6.2, "rate_upper": 9.1 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 9.5, "rate_lower": 7.4, "rate_upper": 11.7 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:41662252 Table 4, household level, quintile 4th; same in pmid:40630579 Table 4" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Household wealth index quintile 5th (wealthiest), pre-census households; distance to facility as covariate", "estimate": { "measure": "incidence rate ratio", "value": 0.77, "lower": 0.5, "upper": 1.05, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 6.7, "rate_lower": 5.1, "rate_upper": 8.2 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 8.6, "rate_lower": 6.3, "rate_upper": 10.9 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:41662252 Table 4, household level, quintile 5th; same in pmid:40630579 Table 4" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Cluster-level wealth index quintile 1st (least wealthy), pre-census households; distance to facility as covariate", "estimate": { "measure": "incidence rate ratio", "value": 0.8, "lower": 0.43, "upper": 1.17, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 11.9, "rate_lower": 8.2, "rate_upper": 15.6 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 14.9, "rate_lower": 9.8, "rate_upper": 20 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:41662252 Table 4, cluster level, quintile 1st; same in pmid:40630579 Table 4" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Cluster-level wealth index quintile 2nd, pre-census households; distance to facility as covariate", "estimate": { "measure": "incidence rate ratio", "value": 0.79, "lower": 0.53, "upper": 1.05, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 10.0, "rate_lower": 7.8, "rate_upper": 12.1 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 12.7, "rate_lower": 9.5, "rate_upper": 15.8 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:41662252 Table 4, cluster level, quintile 2nd; same in pmid:40630579 Table 4" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Cluster-level wealth index quintile 3rd, pre-census households; distance to facility as covariate", "estimate": { "measure": "incidence rate ratio", "value": 0.78, "lower": 0.57, "upper": 0.99, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 8.4, "rate_lower": 7, "rate_upper": 9.7 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 10.8, "rate_lower": 8.4, "rate_upper": 13.1 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:41662252 Table 4, cluster level, quintile 3rd; same in pmid:40630579 Table 4" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Cluster-level wealth index quintile 4th, pre-census households; distance to facility as covariate", "estimate": { "measure": "incidence rate ratio", "value": 0.77, "lower": 0.51, "upper": 1.02, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 7.0, "rate_lower": 5.7, "rate_upper": 8.3 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 9.2, "rate_lower": 6.7, "rate_upper": 11.6 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:41662252 Table 4, cluster level, quintile 4th; same in pmid:40630579 Table 4" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "whole", "subgroup": "Cluster-level wealth index quintile 5th (wealthiest), pre-census households; distance to facility as covariate", "estimate": { "measure": "incidence rate ratio", "value": 0.75, "lower": 0.4, "upper": 1.11, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 5.9, "rate_lower": 4.2, "rate_upper": 7.5 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 7.8, "rate_lower": 4.9, "rate_upper": 10.7 }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:41662252 Table 4, cluster level, quintile 5th; same in pmid:40630579 Table 4" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "6-59 months", "period": "whole", "subgroup": "MUAC ≥ 12.5 cm (no acute malnutrition)", "estimate": { "measure": "incidence rate ratio", "value": 0.84, "lower": 0.68, "upper": 1.06, "level": 0.95 }, "treated": { "deaths": 432, "person_years": 56215, "children": null, "rate_per_1000_person_years": 7.7, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 496, "person_years": 54287, "children": null, "rate_per_1000_person_years": 9.1, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:39466816 Table 2 and Results text" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "6-59 months", "period": "whole", "subgroup": "MUAC < 12.5 cm (acute malnutrition)", "estimate": { "measure": "incidence rate ratio", "value": 0.49, "lower": 0.25, "upper": 0.99, "level": 0.95 }, "treated": { "deaths": 16, "person_years": 942, "children": null, "rate_per_1000_person_years": 17.3, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 32, "person_years": 904, "children": null, "rate_per_1000_person_years": 35.4, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:39466816 Table 2 and Results text" } ], "deaths_ascertainment": "Census at each twice-yearly distribution: 'An enumerative census was conducted during each twice-yearly distribution, during which vital status for all children in the community was collected' (ppr:PPR1068494 abstract). Registry: 'All-cause mortality as determined by biannual census among children aged 1-59 months', over 6 census periods; person-time summed over intercensal periods, children alive at both censuses contributing that period; a cluster not censused (e.g., for security) could re-enter at a later census. Only 284 of 341 communities entered the first census because of security concerns; communities and children lost to follow-up for security were similar between groups (pmid:38349371, Figures 1-2; no counts printed in the text). Census status 'moved' 10.6% vs 9.6% (P = .48) and 'unknown' 0.3% vs 0.2% (P = .66), azithromycin vs placebo (eTable 2). Verbal autopsy was available for 456 (91.6%) deaths in the azithromycin group and 536 (91.2%) in the placebo group (pmid:41252743).", "coverage": "Azithromycin arm: a mean (SD) of 90.1% (16.0%) of the censused children received the scheduled study drug; placebo arm: 89.8% (17.1%) (pmid:38349371, eTable 1). 65 treatments were withheld for reported allergy and 221 for not meeting the weight threshold. pmid:41662252: 'The overall coverage of MDA was approximately 90% for both AZ and placebo arms.'", "notes": "Two printings of the whole-follow-up IRR: 0.82 (95% CI 0.67-1.02) in the main report and 0.82 (0.66 to 1.01) in Table 2 of the SMC secondary analysis (pmid:41021553 and its other version pmid:40343013); both extracted. The main report gives a permutation P value (10 000 replicates) but does not say how its CI was obtained, and the SMC and wealth analyses used Poisson regression with a person-time offset and 'robust standard error' (ppr:PPR1012955 and ppr:PPR1048111 abstracts), not said to be clustered by community, so adjusted_for_clustering is null throughout. Children in the primary entry come from the registry ('Primary analysis included 34399 children in azithromycin clusters and 33847 children placebo clusters'); the main report prints only the total (68 246 children, 119 139 person-years). Season is coded as a subgroup with period 'whole'. The July-December IRR 0.77 (0.6 to 0.98) is printed with a placebo rate of 11.7 (9.5 to 13.9) in Table 2 and 11.6 (9.6 to 13.6) in pmid:40343013 Table 3 'Overall' (that analysis is restricted to July-December per the Figure 5 note); both extracted. Table 3's rows at 30% to 100% SMC coverage are model estimates at those coverage levels, not groups of clusters. pmid:40343013 Table 4 (80% threshold) does not say which months it covers; its all-cluster IRR 0.78 (0.61 to 0.99) differs from the whole-year IRR, and its cluster counts overlap (a cluster can be below 80% in one year and above in another). pmid:41021553 prints the threshold IRRs only in its text (tables in S1 and S2, not printed); the ppr:PPR1012955 abstract is cut off before them. The coverage-adjusted sensitivity analysis by season printed the same IRRs as the main season analysis (cited in those entries). The analysis by quarters gives only an IRD for October-December, -4.0 per 1,000 person-years (95% CI -7.9 to -0.11), not extracted. The wealth tables are identical in pmid:41662252 and pmid:40630579, and the across-quintile IRR is identical at household and cluster level; the wealth-by-arm estimates come from a model with wealth quintile as a linear term and distance to facility as a covariate, in the 15,291 pre-census households (170 clusters). pmid:39466816: Table 1 lists 1,020 (azithromycin) and 1,107 (placebo) children aged 6-59 months with MUAC < 12.5 cm among baseline characteristics; not entered as the subgroup's children because the report does not say how children were assigned to the MUAC subgroups' person-time. Its text gives the MUAC < 12.5 cm IRD upper limit as -0.1 and Table 2 as -0.01 (IRDs not extracted); Fig 3B compares infants 1-11 months by WAZ < -2 but prints no numbers. Communities analysed differ by report: 284 entered the first census (144 azithromycin, 140 placebo; pmid:38349371, pmid:42868154); 146 and 139 analysed or contributing person-time (pmid:41021553, pmid:40343013, pmid:41252743); 297 contributed person-time, 145 and 152 (pmid:39466816). The main report's covariate-adjusted sensitivity analysis was 'nearly identical' (eTable 3), no numbers printed. Cause-specific mortality (pmid:41252743, ppr:PPR1068494), including all infectious causes (IRR 0.80, 0.64-1.01), is not all-cause and not extracted; pmid:42868154 and ppr:PPR1068411 report no mortality. The registry record NCT03676764 also holds the infant-visit trial (T05)." }, { "trial": "T05", "entries": [ { "comparison": "Targeted oral azithromycin vs Targeted oral placebo", "ages": "infants enrolled at 5-12 weeks of age", "period": "whole", "subgroup": null, "estimate": { "measure": "hazard ratio", "value": 1.09, "lower": 0.8, "upper": 1.49, "level": 0.95 }, "treated": { "deaths": 82, "person_years": null, "children": 16416, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 75, "person_years": null, "children": 16461, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": true, "where": "pmid:38231623 abstract (Results; primary end point death before 6 months of age); ClinicalTrials.gov NCT03676764 adverse events module (deaths 82 of 16416, 75 of 16461)" }, { "comparison": "Targeted oral azithromycin vs Targeted oral placebo", "ages": "individually randomized children at 4-12 weeks of age", "period": "whole", "subgroup": null, "estimate": null, "treated": { "deaths": 82, "person_years": null, "children": 15734, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 75, "person_years": null, "children": 15701, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": true, "where": "ClinicalTrials.gov NCT03676764 primary outcome 'All-cause Mortality Rate in Individually Randomized Children at 4-12 Weeks of Age' (time frame 6 months)" } ], "deaths_ascertainment": "'Vital status was assessed at 6 months of age' (pmid:38231623 abstract, Methods). Registry: 'All-cause mortality as determined by a follow-up visit for individually randomized children at healthy child visits', time frame 6 months, over 15734 and 15701 participants (16,416 and 16,461 randomized). No number lost to follow-up is printed for mortality; the growth report (pmid:38261579) included 13,641 (83%) and 13,657 (83%) in its anthropometric analysis, with loss to follow-up 13% of the reasons for exclusion. Verbal autopsy was available for 136 (87%) of 157 deaths: 72 (88%) azithromycin, 64 (85%) placebo (pmid:39317182).", "coverage": "Not printed in the sources.", "notes": "The primary result appears with two sets of denominators: the abstract (82 deaths among 16,416 randomized to azithromycin, 75 among 16,461 to placebo; HR 1.09, 0.80-1.49), matching the registry's adverse events module (82 of 16416, 75 of 16461), and the registry's primary outcome (82 of 15734, 75 of 15701; the cause-specific report's Table 1 uses the same N); both extracted. The registry titles the outcome 'Individually Randomized Children at 4-12 Weeks of Age' while the reports say 5 to 12 weeks. The abstract also gives an absolute difference of 0.04 percentage points (95% CI -0.10 to 0.21) and says there was no evidence of an effect in any prespecified subgroup (age, sex, baseline weight) without printing those estimates. pmid:39317182 prints only cause-specific HRs; pmid:38261579 reports no mortality. pmid:40779591 pools this trial (CHATON) with NAITRE (T06) among infants at risk of poor growth and development: died 63 (1.3%) azithromycin vs 52 (1.1%) placebo, OR 1.19 (0.82 to 1.72), P = 0.36 (Table 3; 4,792 and 4,627 in the mortality analysis; standard errors adjusted for clustering by study); not extracted because it pools two trials and prints no estimate for this trial alone. Individually randomized, so adjusted_for_clustering is null. The registry record NCT03676764 also holds the CHAT community trial (T04)." }, { "trial": "T06", "entries": [ { "comparison": "Azithromycin vs Placebo", "ages": "neonates enrolled at 8-27 days of age", "period": "by 6 months of age", "subgroup": null, "estimate": { "measure": "hazard ratio", "value": 0.85, "lower": 0.56, "upper": 1.28, "level": 0.95 }, "treated": { "deaths": 42, "person_years": null, "children": 9606, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 50, "person_years": null, "children": 9684, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": true, "where": "pmid:35692260 Table 2 'All participants' and Results (Primary Outcome); ClinicalTrials.gov NCT03682653 primary outcome '6 Month Mortality - All Cause' (42 of 9606, 50 of 9684)" }, { "comparison": "Azithromycin vs Placebo", "ages": "enrolled at 8 to 14 days of age", "period": "by 6 months of age", "subgroup": null, "estimate": { "measure": "hazard ratio", "value": 0.85, "lower": 0.53, "upper": 1.38, "level": 0.95 }, "treated": { "deaths": 31, "person_years": null, "children": 7207, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 37, "person_years": null, "children": 7347, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:35692260 Table 2, age at enrollment 8 to 14 days" }, { "comparison": "Azithromycin vs Placebo", "ages": "enrolled at 15 to 21 days of age", "period": "by 6 months of age", "subgroup": null, "estimate": { "measure": "hazard ratio", "value": 0.6, "lower": 0.2, "upper": 1.82, "level": 0.95 }, "treated": { "deaths": 5, "person_years": null, "children": 1634, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 8, "person_years": null, "children": 1562, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:35692260 Table 2, age at enrollment 15 to 21 days" }, { "comparison": "Azithromycin vs Placebo", "ages": "enrolled at 22 to 28 days of age", "period": "by 6 months of age", "subgroup": null, "estimate": { "measure": "hazard ratio", "value": 1.22, "lower": 0.37, "upper": 3.98, "level": 0.95 }, "treated": { "deaths": 6, "person_years": null, "children": 765, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 5, "person_years": null, "children": 774, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:35692260 Table 2, age at enrollment 22 to 28 days" }, { "comparison": "Azithromycin vs Placebo", "ages": "neonates enrolled at 8-27 days of age", "period": "by 6 months of age", "subgroup": "Female", "estimate": { "measure": "hazard ratio", "value": 0.92, "lower": 0.5, "upper": 1.68, "level": 0.95 }, "treated": { "deaths": 20, "person_years": null, "children": 4748, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 22, "person_years": null, "children": 4786, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:35692260 Table 2, child's sex: Female" }, { "comparison": "Azithromycin vs Placebo", "ages": "neonates enrolled at 8-27 days of age", "period": "by 6 months of age", "subgroup": "Male", "estimate": { "measure": "hazard ratio", "value": 0.79, "lower": 0.45, "upper": 1.38, "level": 0.95 }, "treated": { "deaths": 22, "person_years": null, "children": 4858, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 28, "person_years": null, "children": 4898, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:35692260 Table 2, child's sex: Male" }, { "comparison": "Azithromycin vs Placebo", "ages": "neonates enrolled at 8-27 days of age", "period": "by 6 months of age", "subgroup": "Season of enrollment: Rainy (June-October)", "estimate": { "measure": "hazard ratio", "value": 0.68, "lower": 0.36, "upper": 1.28, "level": 0.95 }, "treated": { "deaths": 16, "person_years": null, "children": 4667, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 24, "person_years": null, "children": 4757, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:35692260 Table 2, season of enrollment: Rainy (June-October)" }, { "comparison": "Azithromycin vs Placebo", "ages": "neonates enrolled at 8-27 days of age", "period": "by 6 months of age", "subgroup": "Season of enrollment: Dry (November-May)", "estimate": { "measure": "hazard ratio", "value": 1.0, "lower": 0.58, "upper": 1.72, "level": 0.95 }, "treated": { "deaths": 26, "person_years": null, "children": 4939, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 26, "person_years": null, "children": 4927, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:35692260 Table 2, season of enrollment: Dry (November-May)" }, { "comparison": "Azithromycin vs Placebo", "ages": "neonates enrolled at 8-27 days of age", "period": "by 6 months of age", "subgroup": "Region: Centre", "estimate": { "measure": "hazard ratio", "value": 0.83, "lower": 0.22, "upper": 3.08, "level": 0.95 }, "treated": { "deaths": 4, "person_years": null, "children": 874, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 5, "person_years": null, "children": 904, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:35692260 Table 2, region: Centre" }, { "comparison": "Azithromycin vs Placebo", "ages": "neonates enrolled at 8-27 days of age", "period": "by 6 months of age", "subgroup": "Region: Boucle du Mouhoun", "estimate": { "measure": "hazard ratio", "value": 0.35, "lower": 0.07, "upper": 1.72, "level": 0.95 }, "treated": { "deaths": 2, "person_years": null, "children": 1009, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 6, "person_years": null, "children": 1055, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:35692260 Table 2, region: Boucle du Mouhoun" }, { "comparison": "Azithromycin vs Placebo", "ages": "neonates enrolled at 8-27 days of age", "period": "by 6 months of age", "subgroup": "Region: Cascade", "estimate": { "measure": "hazard ratio", "value": 1.06, "lower": 0.5, "upper": 2.26, "level": 0.95 }, "treated": { "deaths": 14, "person_years": null, "children": 1792, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 13, "person_years": null, "children": 1766, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:35692260 Table 2, region: Cascade" }, { "comparison": "Azithromycin vs Placebo", "ages": "neonates enrolled at 8-27 days of age", "period": "by 6 months of age", "subgroup": "Region: Centre Ouest", "estimate": { "measure": "hazard ratio", "value": 0.99, "lower": 0.25, "upper": 3.95, "level": 0.95 }, "treated": { "deaths": 4, "person_years": null, "children": 1062, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 4, "person_years": null, "children": 1050, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:35692260 Table 2, region: Centre Ouest" }, { "comparison": "Azithromycin vs Placebo", "ages": "neonates enrolled at 8-27 days of age", "period": "by 6 months of age", "subgroup": "Region: Hauts-Bassins", "estimate": { "measure": "hazard ratio", "value": 0.82, "lower": 0.44, "upper": 1.54, "level": 0.95 }, "treated": { "deaths": 18, "person_years": null, "children": 4869, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 22, "person_years": null, "children": 4908, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:35692260 Table 2, region: Hauts-Bassins" }, { "comparison": "Azithromycin vs Placebo", "ages": "neonates enrolled at 8-27 days of age", "period": "by 6 months of age", "subgroup": "Urbanicity: Urban", "estimate": { "measure": "hazard ratio", "value": 0.95, "lower": 0.58, "upper": 1.56, "level": 0.95 }, "treated": { "deaths": 30, "person_years": null, "children": 7239, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 32, "person_years": null, "children": 7333, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:35692260 Table 2, urbanicity: Urban" }, { "comparison": "Azithromycin vs Placebo", "ages": "neonates enrolled at 8-27 days of age", "period": "by 6 months of age", "subgroup": "Urbanicity: Rural", "estimate": { "measure": "hazard ratio", "value": 0.62, "lower": 0.27, "upper": 1.44, "level": 0.95 }, "treated": { "deaths": 9, "person_years": null, "children": 1698, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 14, "person_years": null, "children": 1653, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:35692260 Table 2, urbanicity: Rural" }, { "comparison": "Azithromycin vs Placebo", "ages": "neonates enrolled at 8-27 days of age", "period": "by 6 months of age", "subgroup": "Urbanicity: Peri-urban", "estimate": { "measure": "hazard ratio", "value": 0.78, "lower": 0.17, "upper": 3.48, "level": 0.95 }, "treated": { "deaths": 3, "person_years": null, "children": 663, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 4, "person_years": null, "children": 688, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:35692260 Table 2, urbanicity: Peri-urban" }, { "comparison": "Azithromycin vs Placebo", "ages": "neonates enrolled at 8-27 days of age", "period": "before 28 days of age", "subgroup": null, "estimate": { "measure": "hazard ratio", "value": 1.51, "lower": 0.54, "upper": 4.24, "level": 0.95 }, "treated": { "deaths": 9, "person_years": null, "children": 10485, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 6, "person_years": null, "children": 10547, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:35692260 Table 3 'Death before 28 days of age' and Results (Other outcomes); ClinicalTrials.gov NCT03682653 secondary outcome 'Neonatal Mortality' (9 of 10485, 6 of 10547)" }, { "comparison": "Azithromycin vs Placebo", "ages": "neonates enrolled at 8-27 days of age", "period": "3-month mortality", "subgroup": null, "estimate": { "measure": "hazard ratio", "value": 1.16, "lower": 0.64, "upper": 2.11, "level": 0.95 }, "treated": { "deaths": 23, "person_years": null, "children": 10273, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 20, "person_years": null, "children": 10356, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:35692260 Table 3 '3-month mortality'" }, { "comparison": "Azithromycin vs Placebo", "ages": "neonates enrolled at 8-27 days of age", "period": "within 28 days of treatment", "subgroup": null, "estimate": null, "treated": { "deaths": 16, "person_years": null, "children": 10898, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 8, "person_years": null, "children": 10934, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:35692260 Table 4 'Mortality within 28 days of treatment' (serious adverse events; printed with a risk difference only)" }, { "comparison": "Azithromycin vs Placebo", "ages": "neonates enrolled at 8-27 days of age", "period": "whole", "subgroup": null, "estimate": { "measure": "hazard ratio", "value": 0.81, "lower": 0.56, "upper": 1.17, "level": 0.95 }, "treated": { "deaths": 52, "person_years": null, "children": 9534, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 64, "person_years": null, "children": 9563, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:36343592 Table 2 '12-Month mortality' and Results text (by 12 months of age); ClinicalTrials.gov NCT03682653 secondary outcomes '12 Month Mortality - All Cause' and 'Vital Status' (52 of 9534, 64 of 9563)" }, { "comparison": "Azithromycin vs Placebo", "ages": "neonates enrolled at 8-27 days of age", "period": "not stated (adverse events module)", "subgroup": null, "estimate": null, "treated": { "deaths": 52, "person_years": null, "children": 10898, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 64, "person_years": null, "children": 10934, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "ClinicalTrials.gov NCT03682653 adverse events module, all-cause deaths by group" } ], "deaths_ascertainment": "Vital status at follow-up visits in prespecified windows. 6 months (pmid:35692260): 9,606 (88%) azithromycin and 9,684 (89%) placebo measured in the prespecified 6-month window and included in the primary analysis; another 847 and 805 measured out of window (96% of enrolled infants in each arm in the sensitivity analysis). 12 months (pmid:36343592): 19,097 (87%) had vital status measured in the prespecified window (9,534 azithromycin, 9,563 placebo) and 1,993 more outside it (96% overall with known vital status; 10,508 (96%) and 10,582 (97%) in the sensitivity analysis); no additional deaths were identified outside the window. Registry: 'Caregivers will be asked if the child is dead or alive at 365 days of life.' pmid:37186577: 20,445 (96%) of 21,320 eligible infants were in its mortality analyses, and loss to follow-up did not vary by subgroup or arm. Verbal autopsy was available for 112 (97%) of the 116 deaths by 12 months.", "coverage": "Not printed as a share. 'Five neonates allocated to placebo did not receive their allocated study medication due to not being receptive to taking the study medication' (pmid:35692260); 10,898 allocated to azithromycin and 10,934 to placebo.", "notes": "The primary outcome is 6-month mortality (period 'by 6 months of age', primary true). The 12-month result is coded 'whole' because the registry lists 12-month all-cause mortality and vital status at 365 days of life as secondary outcomes and the 12-month report (pmid:36343592) measured vital status in a prespecified window, so follow-up to 12 months was planned; it is not called primary. The registry's adverse events module gives deaths 52 of 10898 and 64 of 10934 with no time frame (the 12-month death counts over the allocated numbers); extracted separately. 'Mortality within 28 days of treatment' (Table 4, serious adverse events) is printed with a risk difference only, 0.08 (-0.02 to 0.17) percentage points, so its estimate is null. Risks printed as percentages (e.g., 0.44% vs 0.52%) have no field. The 12-month report's '19% relative reduction' restates HR 0.81 without its own interval. Table 2 prints an age-at-enrollment band '22 to 28 days' although enrollment was at 8-27 days; the urbanicity of 15 children is unknown. Randomized to placebo: 10,934 (main report; Table 1 of pmid:36343592) but 10,928 in the text of pmid:36343592. Sensitivity analyses including infants measured outside the window 'did not change results' (Table S3; Supplemental Table 2), numbers not printed. pmid:37186577 compares mortality between nutritional subgroups (not between arms) in its Table 2; its azithromycin vs placebo results by nutritional subgroup are only in S1 Table (P for interaction 0.86), not printed. pmid:40779591 pools NAITRE with CHATON (T05) among infants at risk of poor growth and development: died 63 (1.3%) vs 52 (1.1%), OR 1.19 (0.82 to 1.72), P = 0.36 (Table 3); not extracted because it pools two trials and prints no NAITRE-only estimate. Death and/or hospitalization is a composite and not extracted. Individually randomized, so adjusted_for_clustering is null; the P values are permutation P values." }, { "trial": "T09", "entries": [ { "comparison": "biannual vs annual", "ages": "6 months to <5 years", "period": "whole", "subgroup": null, "estimate": { "measure": "rate ratio", "value": 0.81, "lower": 0.66, "upper": 1.0, "level": 0.95 }, "treated": { "deaths": 173, "person_years": null, "children": null, "rate_per_1000_person_years": 28.9, "rate_lower": 24.8, "rate_upper": 33.6 }, "control": { "deaths": 231, "person_years": null, "children": null, "rate_per_1000_person_years": 35.3, "rate_lower": 30.9, "rate_upper": 40.2 }, "adjusted_for_clustering": true, "primary": false, "where": "pmid:29561511 Results text (cites Table 3)" }, { "comparison": "biannual vs annual", "ages": "6 months to <5 years", "period": "whole", "subgroup": null, "estimate": { "measure": "rate ratio", "value": 0.81, "lower": 0.66, "upper": 1.0, "level": 0.95 }, "treated": { "deaths": 173, "person_years": null, "children": null, "rate_per_1000_person_years": 29.0, "rate_lower": 24.8, "rate_upper": 33.8 }, "control": { "deaths": 231, "person_years": null, "children": null, "rate_per_1000_person_years": 35.6, "rate_lower": 30.9, "rate_upper": 40.9 }, "adjusted_for_clustering": true, "primary": false, "where": "pmid:29561511 Table 3" }, { "comparison": "biannual vs annual", "ages": "<6 months", "period": "whole", "subgroup": null, "estimate": { "measure": "rate ratio", "value": 0.92, "lower": 0.62, "upper": 1.37, "level": 0.95 }, "treated": { "deaths": 66, "person_years": null, "children": null, "rate_per_1000_person_years": 76.3, "rate_lower": 57.8, "rate_upper": 100.9 }, "control": { "deaths": 71, "person_years": null, "children": null, "rate_per_1000_person_years": 83.0, "rate_lower": 62.8, "rate_upper": 109.6 }, "adjusted_for_clustering": true, "primary": false, "where": "pmid:29561511 Table 3" }, { "comparison": "biannual vs annual", "ages": "5 years to <12 years", "period": "whole", "subgroup": null, "estimate": { "measure": "rate ratio", "value": 0.82, "lower": 0.56, "upper": 1.22, "level": 0.95 }, "treated": { "deaths": 53, "person_years": null, "children": null, "rate_per_1000_person_years": 5.6, "rate_lower": 4.1, "rate_upper": 7.4 }, "control": { "deaths": 71, "person_years": null, "children": null, "rate_per_1000_person_years": 6.8, "rate_lower": 5.2, "rate_upper": 8.8 }, "adjusted_for_clustering": true, "primary": false, "where": "pmid:29561511 Table 3" }, { "comparison": "biannual vs annual", "ages": "≥15 years", "period": "whole", "subgroup": null, "estimate": { "measure": "rate ratio", "value": 0.86, "lower": 0.68, "upper": 1.08, "level": 0.95 }, "treated": { "deaths": 132, "person_years": null, "children": null, "rate_per_1000_person_years": 8.4, "rate_lower": 7.1, "rate_upper": 10.0 }, "control": { "deaths": 155, "person_years": null, "children": null, "rate_per_1000_person_years": 9.8, "rate_lower": 8.4, "rate_upper": 11.5 }, "adjusted_for_clustering": true, "primary": false, "where": "pmid:29561511 Table 3" }, { "comparison": "biannual vs annual", "ages": "6 months to <12 years", "period": "whole", "subgroup": null, "estimate": { "measure": "rate ratio", "value": 0.82, "lower": 0.67, "upper": 0.99, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:29561511 Results text (exploratory analysis with children combined into one age group)" } ], "deaths_ascertainment": "How deaths were counted is not described in the Results beyond monitoring of the 48 communities from May 2010 until September 2013; no communities were lost to follow-up. Among children 6 months to <5 years, 497 (18.2%) in the annual arm and 567 (22.1%) in the biannual arm moved out of the study area or were lost to follow-up (no significant difference by arm). Verbal autopsy was available for 362 (89.6%) of the 404 deaths in children 6 months to <5 years.", "coverage": "Children 6 months to <5 years, mean (95% CI) by months after study initiation (pmid:29561511 Table 2). Annual arm: 0, 92.3% (90.3%-94.1%); 12, 89.2% (86.9%-91.3%); 24, 90.1% (88.1%-91.9%); 36, 84.7% (81.2%-88.1%). Biannual arm: 0, 88.4% (84.8%-91.8%); 6, 85.3% (81.8%-88.6%); 12, 87.7% (84.7%-90.6%); 18, 87.3% (83.3%-90.5%); 24, 87.2% (84.4%-89.4%); 30, 84.1% (80.6%-87.4%); 36, 84.6% (81.0%-88.2%). Text: average coverage was greater than 80% across all treatment periods in both arms.", "notes": "Treated is the biannual arm and control the annual arm. For children 6 months to <5 years, the text and Table 3 print the same deaths (231 annual, 173 biannual) and rate ratio 0.81 (0.66-1.00) but different rates: text 35.3 (30.9-40.2) and 28.9 (24.8-33.6), Table 3 35.6 (30.9-40.9) and 29.0 (24.8-33.8); both extracted. adjusted_for_clustering is true for Table 3 (and the text estimate citing it) because the table compares 'community-level mortality rates', with rate ratios and CIs from negative binomial regression and P values by Monte Carlo permutation at the community level accounting for the stratified design; the text estimate for 6 months to <12 years states no method (null). Mortality at 6 months to <5 years is called 'a pre-specified outcome of the trial' in a report titled a secondary analysis, not the primary outcome. Children <6 months were offered tetracycline ointment instead of oral azithromycin in both arms; no age band 12 to <15 years is printed. Infectious-disease mortality (rate ratio 0.73, 0.57-0.94) is not all-cause and not extracted. Table 2 lists coverage at 36 months in both arms although the text describes annual distributions at June/July 2010, 2011, and 2012 plus three extra biannual rounds. The registry record NCT00792922 posts only trachoma outcomes, and its adverse events module gives 'deaths None of None'." }, { "trial": "T10", "entries": [ { "comparison": "arms A, B, and C together vs arm D (delayed treatment)", "ages": "1-9 years", "period": "whole", "subgroup": null, "estimate": { "measure": "odds ratio", "value": 0.51, "lower": 0.29, "upper": 0.9, "level": 0.95 }, "treated": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 4.1, "rate_lower": 3.0, "rate_upper": 5.7 }, "control": { "deaths": null, "person_years": null, "children": null, "rate_per_1000_person_years": 8.3, "rate_lower": 5.3, "rate_upper": 13.1 }, "adjusted_for_clustering": true, "primary": false, "where": "pmid:19724043 abstract (Results; clustered logistic regression)" } ], "deaths_ascertainment": "'Mortality was measured by enumerative census at baseline and again after 1 year' (pmid:19724043 abstract). No number lost to follow-up is printed for this comparison. (pmid:23545893 used the 12-month census; pmid:21427395, a cohort analysis of a single mass treatment in 24 subkebeles, used a census 26 months after baseline, in which 2083 persons who had received antibiotics and 674 who had not moved away and were lost to follow-up.)", "coverage": "'Antibiotic coverage levels for children aged 1 to 9 years exceeded 80% at all visits' (pmid:19724043 abstract; not given per arm). pmid:23545893 (older ages): in arms A and B, 11 977 of 14115 persons (84.9%) aged 10 to 29 years and 7252 of 8217 (88.3%) aged 30 years or older received azithromycin; in arms C and D, 757 of 13996 (5.4%) and 109 of 8320 (1.3%) mistakenly received it. pmid:21427395 cohort: 31,133 (88.8%) of cohort members aged 1 year or older received azithromycin at baseline, including 4914 children 1-5 years (89.2%).", "notes": "Only the combined comparison (the intervention communities of arms A, B, and C vs the delayed-treatment arm D) is printed, from the main report's abstract (no open full text); no estimate is printed for A vs D, B vs D, or C vs D. The abstract's wording ('In the treated communities, the estimated overall mortality rate during this period for children aged 1 to 9 years in the untreated group was 8.3 ..., while among the treated communities ... 4.1') is read as control 8.3 and treated 4.1. Mortality is the report's main outcome measure and 'a prespecified outcome for the clinical trial', not called the trial's primary outcome. The participants per arm in the abstract (15,902; 17,288; 14,716; 18,498) count all participants, not children aged 1-9, so children is null. Not extracted: pmid:21427395 compares individuals who did and did not receive a single mass azithromycin treatment within 24 treated subkebeles, not a randomized or listed comparison (e.g., 1-5 years: 2.79 vs 8.18 per 1000 person-years, OR 0.35, 0.17-0.74); pmid:23545893 compares arms A+B with arms C+D at ages 10-29 years (OR 0.69, 0.37-1.29) and 30 years or older (Table OR 0.89, 0.62-1.29; text 0.91, 0.63-1.30), not a listed comparison." }, { "trial": "T12", "entries": [], "deaths_ascertainment": "Not described in the Results; the main report's abstract (Methods) says data were recorded by means of active and passive surveillance. No number lost to follow-up is printed.", "coverage": "Not printed as shares per arm. pmid:33417683: 30 629 (98.9%) of 30 977 study children received at least 1 dose of study medication (15 290 SMC plus azithromycin, 15 339 SMC plus placebo); >65% received all 4 monthly cycles each year and >84% at least 3 cycles; adherence to the 3-day regimen in children who received the first dose was >91% at all SMC contacts and >96% at 9 of the 12 contacts.", "notes": "No all-cause mortality result is printed, so no entries. The main report (abstract only) gives the composite primary end point of death or hospital admission not due to trauma or elective surgery: 250 vs 238 events, 24.8 vs 23.5 per 1000 child-years at risk, incidence rate ratio 1.1 (95% CI 0.88 to 1.3); pmid:33417683 gives the same composite by days since the last SMC course (Table 2). Deaths are not separated from hospital admissions in either source." }, { "trial": "T13", "entries": [], "deaths_ascertainment": null, "coverage": null, "notes": "The only source is the trial protocol's abstract (ppr:PPR918006); it prints no results, so no entries. Its planned primary outcome is all-cause mortality rate at 18 months of age, assessed through mortality surveillance." } ]