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false, "where": "pmid:30561577 Results (Cox proportional hazard model, stratified by country)", "ages_lo": 1.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T01-MW", "source_role": "secondary", "decided_by": "agreed" }, { "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)", "ages_lo": 1.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T01-TZ", "source_role": "secondary", "decided_by": "agreed" }, { "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)", "ages_lo": 1.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T01-NE", "source_role": "secondary", "decided_by": "agreed" }, { "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", "ages_lo": 1.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T01-MW", "source_role": "secondary", "decided_by": "agreed" }, { "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", "ages_lo": 1.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T01-MW", "source_role": "secondary", "decided_by": "agreed" }, { "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)", "ages_lo": 1.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T01-all", "source_role": "secondary", "decided_by": "agreed" }, { "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)", "ages_lo": 1.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T01-all", "source_role": "secondary", "decided_by": "agreed" }, { "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)", "ages_lo": 1.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T01-all", "source_role": "secondary", "decided_by": "agreed" }, { "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)", "ages_lo": 1.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T01-all", "source_role": "secondary", "decided_by": "agreed" }, { "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)", "ages_lo": 1.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T01-all", "source_role": "secondary", "decided_by": "agreed" }, { "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)", "ages_lo": 1.0, "ages_hi": 11.0, "period_mid_years": null, "comparison_id": "T01-all", "source_role": "secondary", "decided_by": "agreed" }, { "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)", "ages_lo": 1.0, "ages_hi": 11.0, "period_mid_years": null, "comparison_id": "T01-all", "source_role": "secondary", "decided_by": "agreed" }, { "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)", "ages_lo": 1.0, "ages_hi": 11.0, "period_mid_years": null, "comparison_id": "T01-all", "source_role": "secondary", "decided_by": "agreed" }, { "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)", "ages_lo": 1.0, "ages_hi": 11.0, "period_mid_years": null, "comparison_id": "T01-all", "source_role": "secondary", "decided_by": "agreed" }, { "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", "ages_lo": 1.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T01-NE", "source_role": "secondary", "decided_by": "agreed" }, { "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)", "ages_lo": 1.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T01-NE", "source_role": "secondary", "decided_by": "agreed" }, { "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", "ages_lo": 1.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T01-all", "source_role": "secondary", "decided_by": "agreed" }, { "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", "ages_lo": 1.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T01-all", "source_role": "secondary", "decided_by": "agreed" }, { "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)", "ages_lo": 1.0, "ages_hi": 60.0, "period_mid_years": null, "comparison_id": "T01-all", "source_role": "registry", "decided_by": "agreed" }, { "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)", "ages_lo": 1.0, "ages_hi": 60.0, "period_mid_years": null, "comparison_id": "T01-NE", "source_role": "registry", "decided_by": "agreed" }, { "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", "ages_lo": 1.0, "ages_hi": 60.0, "period_mid_years": null, "comparison_id": "T01-NE", "source_role": "registry", "decided_by": "agreed" }, { "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)", "ages_lo": 1.0, "ages_hi": 11.0, "period_mid_years": null, "comparison_id": "T01-all", "source_role": "secondary", "decided_by": "agreed" }, { "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)", "ages_lo": 1.0, "ages_hi": 11.0, "period_mid_years": null, "comparison_id": "T01-all", "source_role": "secondary", "decided_by": "agreed" }, { "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)", "ages_lo": 1.0, "ages_hi": 11.0, "period_mid_years": null, "comparison_id": "T01-all", "source_role": "secondary", "decided_by": "agreed" }, { "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", "ages_lo": 1.0, "ages_hi": 11.0, "period_mid_years": null, "comparison_id": "T01-all", "source_role": "secondary", "decided_by": "agreed" }, { "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", "ages_lo": 1.0, "ages_hi": 11.0, "period_mid_years": null, "comparison_id": "T01-all", "source_role": "secondary", "decided_by": "agreed" }, { "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", "ages_lo": 1.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T01-all", "source_role": "secondary", "decided_by": "agreed" }, { "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", "ages_lo": 1.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T01-all", "source_role": "secondary", "decided_by": "agreed" }, { "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", "ages_lo": 1.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T01-all", "source_role": "secondary", "decided_by": "agreed" }, { "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", "ages_lo": 1.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T01-all", "source_role": "secondary", "decided_by": "agreed" }, { "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": 40345, "rate_per_1000_person_years": 22.32, "rate_lower": 20.86, "rate_upper": 23.87 }, "control": { "deaths": 1735, "person_years": null, "children": 35747, "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 (only deaths whose cause the verbal autopsy ascertained; negative binomial regression of community-level death counts); children from the Results text (enrolled at baseline), the same numbers NCT02047981 posts as the participants of its Niger verbal-autopsy outcome", "note": "Counts only deaths whose cause the verbal autopsy ascertained: 1566 of the 1727 census deaths in the azithromycin group and 1735 of the 1888 in the placebo group (Table 2, Results text). Children are those enrolled at baseline.", "ages_lo": 1.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T01-NE", "source_role": "secondary", "decided_by": "third reader" }, { "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": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 200, "person_years": 33638, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:34559801 Results text", "note": "Rates printed per 100 person-years, not per 1000: 0.58 (azithromycin) and 0.59 (placebo) deaths/100 person-years over the course of the study. No ratio is printed; the text says only that a difference by treatment assignment was not significant after adjusting for community clustering.", "ages_lo": 1.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T01-TZ", "source_role": "secondary", "decided_by": "third reader" }, { "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": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 32, "person_years": 2230.5, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": true, "primary": false, "where": "pmid:34559801 Table 1 (age-group specific negative binomial regression models at the community level)", "note": "Table 1 prints incidence rates per 100 person-years, not per 1000: 1.14 (azithromycin) and 1.43 (placebo).", "ages_lo": 1.0, "ages_hi": 5.0, "period_mid_years": null, "comparison_id": "T01-TZ", "source_role": "secondary", "decided_by": "third reader" }, { "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": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 45, "person_years": 3597.1, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": true, "primary": false, "where": "pmid:34559801 Table 1 (age-group specific negative binomial regression models at the community level)", "note": "Table 1 prints incidence rates per 100 person-years, not per 1000: 1.17 (azithromycin) and 1.25 (placebo).", "ages_lo": 6.0, "ages_hi": 11.0, "period_mid_years": null, "comparison_id": "T01-TZ", "source_role": "secondary", "decided_by": "third reader" }, { "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": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 60, "person_years": 7926.0, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": true, "primary": false, "where": "pmid:34559801 Table 1 (age-group specific negative binomial regression models at the community level)", "note": "Table 1 prints incidence rates per 100 person-years, not per 1000: 0.78 (azithromycin) and 0.76 (placebo).", "ages_lo": 12.0, "ages_hi": 23.0, "period_mid_years": null, "comparison_id": "T01-TZ", "source_role": "secondary", "decided_by": "third reader" }, { "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": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 63, "person_years": 19888.5, "children": null, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": true, "primary": false, "where": "pmid:34559801 Table 1 (age-group specific negative binomial regression models at the community level)", "note": "Table 1 prints incidence rates per 100 person-years, not per 1000: 0.33 (azithromycin) and 0.32 (placebo).", "ages_lo": 24.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T01-TZ", "source_role": "secondary", "decided_by": "third reader" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-60 months", "period": "not printed", "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 (ages from the group descriptions: children aged 1 month to 60 months)", "note": "The adverse events module prints deaths by group with no time frame. Its denominators (97047, 93191) are the participants of the registry's 24-month primary outcome; the group descriptions add that in Niger during year 3 all communities were offered azithromycin.", "ages_lo": 1.0, "ages_hi": 60.0, "period_mid_years": null, "comparison_id": "T01-all", "source_role": "registry", "decided_by": "third reader" } ], "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)." }, { "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", "ages_lo": 1.0, "ages_hi": 60.0, "period_mid_years": null, "comparison_id": "T02-1", "source_role": "registry", "decided_by": "agreed" }, { "comparison": "Azithro vs Placebo", "ages": "1-60 months", "period": "not printed", "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 (ages from the group descriptions: children aged 1 month to 60 months)", "note": "The adverse events module prints deaths by group with no time frame. Its denominators (33173, 33055) are the participants of the registry's 24-month primary outcome.", "ages_lo": 1.0, "ages_hi": 60.0, "period_mid_years": null, "comparison_id": "T02-1", "source_role": "registry", "decided_by": "third reader" } ], "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 }, { "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 }, 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"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)", "ages_lo": 1.0, "ages_hi": 11.0, "period_mid_years": null, "comparison_id": "T03-child", "source_role": "secondary", "decided_by": "agreed" }, { "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", "ages_lo": 1.0, "ages_hi": 11.0, "period_mid_years": null, "comparison_id": "T03-infant", "source_role": "secondary", "decided_by": "agreed" }, { "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)", "ages_lo": 1.0, "ages_hi": 11.0, "period_mid_years": null, "comparison_id": "T03-infant", "source_role": "secondary", "decided_by": "agreed" }, { "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)", "ages_lo": 1.0, "ages_hi": 11.0, "period_mid_years": null, "comparison_id": "T03-infant", "source_role": "secondary", "decided_by": "agreed" }, { "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)", "ages_lo": 1.0, "ages_hi": 11.0, "period_mid_years": null, "comparison_id": "T03-infant", "source_role": "secondary", "decided_by": "agreed" }, { "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)", "ages_lo": 1.0, "ages_hi": 11.0, "period_mid_years": null, "comparison_id": "T03-infant", "source_role": "secondary", "decided_by": "agreed" }, { "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", "ages_lo": 1.0, "ages_hi": 11.0, "period_mid_years": null, "comparison_id": "T03-within", "source_role": "secondary", "decided_by": "agreed" }, { "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)", "ages_lo": 1.0, "ages_hi": 11.0, "period_mid_years": null, "comparison_id": "T03-within", "source_role": "secondary", "decided_by": "agreed" }, { "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)", "ages_lo": 1.0, "ages_hi": 11.0, "period_mid_years": null, "comparison_id": "T03-within", "source_role": "secondary", "decided_by": "agreed" }, { "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)", "ages_lo": 1.0, "ages_hi": 11.0, "period_mid_years": null, "comparison_id": "T03-within", "source_role": "secondary", "decided_by": "agreed" }, { "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)", "ages_lo": 1.0, "ages_hi": 11.0, "period_mid_years": null, "comparison_id": "T03-within", "source_role": "secondary", "decided_by": "agreed" }, { "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", "ages_lo": 1.0, "ages_hi": 11.0, "period_mid_years": null, "comparison_id": "T03-child", "source_role": "registry", "decided_by": "agreed" }, { "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", "ages_lo": 1.0, "ages_hi": 11.0, "period_mid_years": null, "comparison_id": "T03-infant", "source_role": "registry", "decided_by": "agreed" }, { "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", "ages_lo": 1.0, "ages_hi": 11.0, "period_mid_years": null, "comparison_id": "T03-within", "source_role": "registry", "decided_by": "agreed" }, { "comparison": "Azithro 1-59 vs Placebo", "ages": "1-59 months", "period": "not printed", "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 (ages from the group descriptions: children 1-59 months)", "note": "The adverse events module prints deaths by group with no time frame. Its denominators (Azithro 1-11 104374, Azithro 1-59 153626, Placebo 124617) are the participants of the registry's primary outcome for children 1-59 months.", "ages_lo": 1.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T03-child", "source_role": "registry", "decided_by": "third reader" }, { "comparison": "Azithro 1-11 vs Placebo", "ages": "1-59 months", "period": "not printed", "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 (ages from the group descriptions: children 1-59 months)", "note": "The adverse events module prints deaths by group with no time frame. Its denominators (Azithro 1-11 104374, Azithro 1-59 153626, Placebo 124617) are the participants of the registry's primary outcome for children 1-59 months.", "ages_lo": 1.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T03-infant", "source_role": "registry", "decided_by": "third reader" }, { "comparison": "Azithro 1-59 vs Azithro 1-11", "ages": "1-59 months", "period": "not printed", "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 (ages from the group descriptions: children 1-59 months)", "note": "The adverse events module prints deaths by group with no time frame. Its denominators (Azithro 1-11 104374, Azithro 1-59 153626, Placebo 124617) are the participants of the registry's primary outcome for children 1-59 months.", "ages_lo": 1.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T03-within", "source_role": "registry", "decided_by": "third reader" } ], "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." }, { "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)", "ages_lo": 1.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T04-1", "source_role": "main", "decided_by": "agreed" }, { "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)", "ages_lo": 1.0, "ages_hi": 11.0, "period_mid_years": null, "comparison_id": "T04-1", "source_role": "main", "decided_by": "agreed" }, { "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)", "ages_lo": 12.0, "ages_hi": 23.0, "period_mid_years": null, "comparison_id": "T04-1", "source_role": "main", "decided_by": "agreed" }, { "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)", "ages_lo": 24.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T04-1", "source_role": "main", "decided_by": "agreed" }, { "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)", "ages_lo": 1.0, "ages_hi": 59.0, "period_mid_years": 0.5, "comparison_id": "T04-1", "source_role": "main", "decided_by": "agreed" }, { "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)", "ages_lo": 1.0, "ages_hi": 59.0, "period_mid_years": 1.5, "comparison_id": "T04-1", "source_role": "main", "decided_by": "agreed" }, { "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)", "ages_lo": 1.0, "ages_hi": 59.0, "period_mid_years": 2.5, "comparison_id": "T04-1", "source_role": "main", "decided_by": "agreed" }, { "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)", "ages_lo": 1.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T04-1", "source_role": "secondary", "decided_by": "agreed" }, { "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)", "ages_lo": 1.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T04-1", "source_role": "secondary", "decided_by": "agreed" }, { "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", "ages_lo": 6.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T04-1", "source_role": "secondary", "decided_by": "agreed" }, { "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", "ages_lo": 6.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T04-1", "source_role": "secondary", "decided_by": "agreed" }, { "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)", "ages_lo": 1.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T04-1", "source_role": "secondary", "decided_by": "agreed" }, { "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)", "ages_lo": 1.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T04-1", "source_role": "secondary", "decided_by": "agreed" }, { "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)", "ages_lo": 1.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T04-1", "source_role": "secondary", "decided_by": "agreed" }, { "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)", "ages_lo": 1.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T04-1", "source_role": "secondary", "decided_by": "agreed" }, { "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)", "ages_lo": 1.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T04-1", "source_role": "secondary", "decided_by": "agreed" }, { "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)", "ages_lo": 1.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T04-1", "source_role": "secondary", "decided_by": "agreed" }, { "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)", "ages_lo": 1.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T04-1", "source_role": "secondary", "decided_by": "agreed" }, { "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)", "ages_lo": 1.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T04-1", "source_role": "secondary", "decided_by": "agreed" }, { "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)", "ages_lo": 1.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T04-1", "source_role": "secondary", "decided_by": "agreed" }, { "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", "ages_lo": 1.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T04-1", "source_role": "secondary", "decided_by": "agreed" }, { "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", "ages_lo": 1.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T04-1", "source_role": "secondary", "decided_by": "agreed" }, { "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", "ages_lo": 1.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T04-1", "source_role": "secondary", "decided_by": "agreed" }, { "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", "ages_lo": 1.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T04-1", "source_role": "secondary", "decided_by": "agreed" }, { "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", "ages_lo": 1.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T04-1", "source_role": "secondary", "decided_by": "agreed" }, { "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", "ages_lo": 1.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T04-1", "source_role": "secondary", "decided_by": "agreed" }, { "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", "ages_lo": 1.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T04-1", "source_role": "secondary", "decided_by": "agreed" }, { "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", "ages_lo": 1.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T04-1", "source_role": "secondary", "decided_by": "agreed" }, { "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", "ages_lo": 1.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T04-1", "source_role": "secondary", "decided_by": "agreed" }, { "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", "ages_lo": 1.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T04-1", "source_role": "secondary", "decided_by": "agreed" }, { "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", "ages_lo": 1.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T04-1", "source_role": "secondary", "decided_by": "agreed" }, { "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", "note": "Children are Table 1's 'Number of Children' for the 146 azithromycin and 139 placebo communities analysed; NCT03676764 states its primary analysis included 34399 and 33847 children. The main report (pmid:38349371) prints the overall IRR as 0.82 (95% CI 0.67-1.02).", "ages_lo": 1.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T04-1", "source_role": "secondary", "decided_by": "third reader" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "not printed", "subgroup": "clusters with SMC coverage below 80% (N=222)", "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; the IRR is also in pmid:41021553 Results text (its S1 and S2 Tables are not in the sources)", "note": "Table 4 prints no period. The note to Figure 5 (rates by SMC coverage level, the analysis in Table 3) says that analysis was restricted to months during and after SMC distribution (July-December). Table 4's note: some clusters may appear in both high and low coverage counts if their estimates were above the threshold in one year and below the threshold in another year.", "ages_lo": 1.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T04-1", "source_role": "secondary", "decided_by": "third reader" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "not printed", "subgroup": "clusters with SMC coverage of 80% or above (N=86)", "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; the IRR is also in pmid:41021553 Results text (its S1 and S2 Tables are not in the sources)", "note": "Table 4 prints no period. The note to Figure 5 (rates by SMC coverage level, the analysis in Table 3) says that analysis was restricted to months during and after SMC distribution (July-December). Table 4's note: some clusters may appear in both high and low coverage counts if their estimates were above the threshold in one year and below the threshold in another year.", "ages_lo": 1.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T04-1", "source_role": "secondary", "decided_by": "third reader" }, { "comparison": "Biannual mass oral azithromycin vs Biannual mass oral placebo", "ages": "1-59 months", "period": "not printed", "subgroup": null, "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)'", "note": "Table 4 prints no period. The note to Figure 5 (rates by SMC coverage level, the analysis in Table 3) says that analysis was restricted to months during and after SMC distribution (July-December). Table 4's 'Across all clusters' rates (9.0 and 11.5 per 1000 person-years) differ from Table 2's 'Overall (Jan-Dec)' rates (8.2 and 10.0).", "ages_lo": 1.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T04-1", "source_role": "secondary", "decided_by": "third reader" } ], "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.'" }, { "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)", "ages_lo": 1.15, "ages_hi": 2.76, "period_mid_years": null, "comparison_id": "T05-1", "source_role": "main", "decided_by": "agreed" }, { "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)", "ages_lo": 0.92, "ages_hi": 2.76, "period_mid_years": null, "comparison_id": "T05-1", "source_role": "registry", "decided_by": "agreed" } ], "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." }, { "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)", "ages_lo": 0.26, "ages_hi": 0.89, "period_mid_years": null, "comparison_id": "T06-1", "source_role": "main", "decided_by": "agreed" }, { "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", "ages_lo": 0.26, "ages_hi": 0.46, "period_mid_years": null, "comparison_id": "T06-1", "source_role": "main", "decided_by": "agreed" }, { "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", "ages_lo": 0.49, "ages_hi": 0.69, "period_mid_years": null, "comparison_id": "T06-1", "source_role": "main", "decided_by": "agreed" }, { "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", "ages_lo": 0.72, "ages_hi": 0.92, "period_mid_years": null, "comparison_id": "T06-1", "source_role": "main", "decided_by": "agreed" }, { "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", "ages_lo": 0.26, "ages_hi": 0.89, "period_mid_years": null, "comparison_id": "T06-1", "source_role": "main", "decided_by": "agreed" }, { "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", "ages_lo": 0.26, "ages_hi": 0.89, "period_mid_years": null, "comparison_id": "T06-1", "source_role": "main", "decided_by": "agreed" }, { "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", "ages_lo": 0.26, "ages_hi": 0.89, "period_mid_years": null, "comparison_id": "T06-1", "source_role": "main", "decided_by": "agreed" }, { "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", "ages_lo": 0.26, "ages_hi": 0.89, "period_mid_years": null, "comparison_id": "T06-1", "source_role": "main", "decided_by": "agreed" }, { "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", "ages_lo": 0.26, "ages_hi": 0.89, "period_mid_years": null, "comparison_id": "T06-1", "source_role": "main", "decided_by": "agreed" }, { "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", "ages_lo": 0.26, "ages_hi": 0.89, "period_mid_years": null, "comparison_id": "T06-1", "source_role": "main", "decided_by": "agreed" }, { "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", "ages_lo": 0.26, "ages_hi": 0.89, "period_mid_years": null, "comparison_id": "T06-1", "source_role": "main", "decided_by": "agreed" }, { "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", "ages_lo": 0.26, "ages_hi": 0.89, "period_mid_years": null, "comparison_id": "T06-1", "source_role": "main", "decided_by": "agreed" }, { "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", "ages_lo": 0.26, "ages_hi": 0.89, "period_mid_years": null, "comparison_id": "T06-1", "source_role": "main", "decided_by": "agreed" }, { "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", "ages_lo": 0.26, "ages_hi": 0.89, "period_mid_years": null, "comparison_id": "T06-1", "source_role": "main", "decided_by": "agreed" }, { "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)", "ages_lo": 0.26, "ages_hi": 0.89, "period_mid_years": null, "comparison_id": "T06-1", "source_role": "main", "decided_by": "agreed" }, { "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'", "ages_lo": 0.26, "ages_hi": 0.89, "period_mid_years": null, "comparison_id": "T06-1", "source_role": "main", "decided_by": "agreed" }, { "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)", "ages_lo": 0.26, "ages_hi": 0.89, "period_mid_years": null, "comparison_id": "T06-1", "source_role": "main", "decided_by": "agreed" }, { "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)", "ages_lo": 0.26, "ages_hi": 0.89, "period_mid_years": null, "comparison_id": "T06-1", "source_role": "secondary", "decided_by": "agreed" }, { "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", "ages_lo": 0.26, "ages_hi": 0.89, "period_mid_years": null, "comparison_id": "T06-1", "source_role": "registry", "decided_by": "agreed" }, { "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)", "ages_lo": 0.26, "ages_hi": 0.89, "period_mid_years": null, "comparison_id": "T06-1", "source_role": "main", "decided_by": "agreed" }, { "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)", "ages_lo": 0.26, "ages_hi": 0.89, "period_mid_years": null, "comparison_id": "T06-1", "source_role": "main", "decided_by": "agreed" } ], "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." }, { "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)", "ages_lo": 1.0, "ages_hi": 11.0, "period_mid_years": null, "comparison_id": "T07-2x", "source_role": "main", "decided_by": "agreed" }, { "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)", "ages_lo": 1.0, "ages_hi": 11.0, "period_mid_years": null, "comparison_id": "T07-4x", "source_role": "main", "decided_by": "agreed" }, { "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)", "ages_lo": 1.0, "ages_hi": 11.0, "period_mid_years": null, "comparison_id": "T07-4v2", "source_role": "main", "decided_by": "agreed" }, { "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)", "ages_lo": 12.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T07-2x", "source_role": "main", "decided_by": "agreed" }, { "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)", "ages_lo": 12.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T07-4x", "source_role": "main", "decided_by": "agreed" } ], "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)." }, { "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)", "ages_lo": 1.0, "ages_hi": 11.0, "period_mid_years": null, "comparison_id": "T08-1", "source_role": "main", "decided_by": "agreed" }, { "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)", "ages_lo": 1.0, "ages_hi": 11.0, "period_mid_years": null, "comparison_id": "T08-1", "source_role": "main", "decided_by": "agreed" }, { "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": null, "rate_lower": null, "rate_upper": null }, "control": { "deaths": 247, "person_years": null, "children": 97205, "rate_per_1000_person_years": null, "rate_lower": null, "rate_upper": null }, "adjusted_for_clustering": null, "primary": false, "where": "pmid:41506755 Results text, secondary analysis of cumulative probabilities of mortality with a synthetic cohort (online supplemental table 4 is not in the sources)", "note": "Mortality printed per 1000 live births, not per 1000 person-years: 3.3 (95% CI 2.7 to 3.9) in azithromycin communities and 3.1 (95% CI 2.3 to 3.9) in placebo communities. Children are live births in the synthetic cohort.", "ages_lo": 1.0, "ages_hi": 11.0, "period_mid_years": null, "comparison_id": "T08-1", "source_role": "main", "decided_by": "third reader" } ], "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)." }, { "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)", "ages_lo": 6.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T09-1", "source_role": "main", "decided_by": "agreed" }, { "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", "ages_lo": 6.0, "ages_hi": 59.0, "period_mid_years": null, "comparison_id": "T09-1", "source_role": "main", "decided_by": "agreed" }, { "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", "ages_lo": 1, "ages_hi": 5.0, "period_mid_years": null, "comparison_id": "T09-1", "source_role": "main", "decided_by": "agreed" }, { "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", "ages_lo": 60.0, "ages_hi": 143.0, "period_mid_years": null, "comparison_id": "T09-1", "source_role": "main", "decided_by": "agreed" }, { "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", "ages_lo": null, "ages_hi": null, "period_mid_years": null, "comparison_id": "T09-1", "source_role": "main", "decided_by": "agreed" }, { "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)", "ages_lo": 6.0, "ages_hi": 143.0, "period_mid_years": null, "comparison_id": "T09-1", "source_role": "main", "decided_by": "agreed" } ], "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." }, { "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)", "ages_lo": 12.0, "ages_hi": 119.0, "period_mid_years": null, "comparison_id": "T10-ABC", "source_role": "main", "decided_by": "agreed" } ], "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%)." }, { "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." }, { "trial": "T13", "entries": [], "deaths_ascertainment": null, "coverage": null } ]