[ { "trial": "T11", "eligible": true, "exclusion_reason": null, "unit": "community", "units": null, "countries": [ "Ethiopia" ], "period": { "start": "2010-11", "end": "2013-11" }, "arms": [ { "label": "Arm J: stop annual treatment", "azithromycin_ages": null, "placebo_ages": null, "frequency": null, "rounds": 0, "dose": null }, { "label": "Arm K: stop biannual treatment", "azithromycin_ages": null, "placebo_ages": null, "frequency": null, "rounds": 0, "dose": null }, { "label": "Arm L: continue annual treatment", "azithromycin_ages": "all ages >= 6 months (pregnant women excluded)", "placebo_ages": null, "frequency": "annual", "rounds": null, "dose": null }, { "label": "Arm M: continue biannual treatment", "azithromycin_ages": "all ages >= 6 months (pregnant women excluded)", "placebo_ages": null, "frequency": "biannual", "rounds": null, "dose": null }, { "label": "Arm N: targeted treatment by age", "azithromycin_ages": "pre-school-aged children (band not stated; >= 6 months)", "placebo_ages": null, "frequency": null, "rounds": null, "dose": null }, { "label": "Arm O: targeted treatment by clinical exam", "azithromycin_ages": "members of households in which a pre-school-aged child has clinically active trachoma (>= 6 months, pregnant women excluded)", "placebo_ages": null, "frequency": null, "rounds": null, "dose": null } ], "control": "no_treatment", "masking": "single", "strategy": "community_wide_mda", "comparisons": [ { "treated_arm": "Arm L: continue annual treatment", "control_arm": "Arm J: stop annual treatment", "strategy": "community_wide_mda" }, { "treated_arm": "Arm M: continue biannual treatment", "control_arm": "Arm K: stop biannual treatment", "strategy": "community_wide_mda" }, { "treated_arm": "Arm N: targeted treatment by age", "control_arm": "Arm J: stop annual treatment + Arm K: stop biannual treatment", "strategy": "other" } ], "mortality_outcome": { "ages": "6 months-5 years (also 6-10 and >10 years)", "ascertainment": null, "primary": false, "description": "Childhood mortality (6 months-5 years, 6-10 years, >10 years) at 36 months, a registered secondary outcome; Aim 6 asks whether under-5 mortality is lower with mass azithromycin than with no treatment. How deaths were ascertained is not stated." }, "co_interventions": [], "registration": [ "NCT01202331" ], "notes": "Registry text only: TIRET randomizes a subset of TANA communities to stop or continue annual or biannual mass treatment, or to treatment targeted to pre-school children (N) or to households of a pre-school child with clinically active trachoma (O), and no arm gives azithromycin to children under 6 months or pregnant women. Arm sizes, doses, rounds, the targeted arms' age bands and schedules, and how deaths were ascertained are not given; each continue arm is paired with the stop arm of its schedule, N (other, as its band starts at 6 months) with both stop arms, and O is left out because it is targeted by clinical exam rather than given regardless of illness.", "third_reader_reason": "Kept both coders' continue-versus-stop comparisons (community_wide_mda) and coder 2's N against both stop arms as other: N gives azithromycin to every pre-school child from 6 months regardless of illness, and childhood mortality is registered for the whole trial, but its band leaves out 1-5 months. Dropped coder 2's O comparison, since O treats only households where a pre-school child has clinically active trachoma, so it is not azithromycin at population scale regardless of illness." }, { "trial": "T14", "eligible": true, "exclusion_reason": null, "unit": "individual", "units": null, "countries": [ "Mali" ], "period": { "start": "2020-09", "end": "2025-03" }, "arms": [ { "label": "Maternal AZ, infant AZ", "azithromycin_ages": "infants at Penta-1 and Penta-3 visits (about 6 and 14 weeks; first dose at >= 6 weeks)", "placebo_ages": null, "frequency": "two doses, at Penta-1 and Penta-3 visits", "rounds": 2, "dose": "infants 20 mg/kg (max 1 g); mothers 2 g at up to 2 antenatal visits and delivery" }, { "label": "Maternal AZ, infant placebo", "azithromycin_ages": null, "placebo_ages": "infants at Penta-1 and Penta-3 visits (about 6 and 14 weeks)", "frequency": "two doses, at Penta-1 and Penta-3 visits", "rounds": 2, "dose": "mothers 2 g at up to 2 antenatal visits and delivery; placebo to infants" }, { "label": "Maternal placebo, infant AZ", "azithromycin_ages": "infants at Penta-1 and Penta-3 visits (about 6 and 14 weeks; first dose at >= 6 weeks)", "placebo_ages": null, "frequency": "two doses, at Penta-1 and Penta-3 visits", "rounds": 2, "dose": "infants 20 mg/kg (max 1 g)" }, { "label": "Maternal placebo, infant placebo", "azithromycin_ages": null, "placebo_ages": "infants at Penta-1 and Penta-3 visits (about 6 and 14 weeks)", "frequency": "two doses, at Penta-1 and Penta-3 visits", "rounds": 2, "dose": null }, { "label": "Infant-only cohort, AZ", "azithromycin_ages": "infants 6 weeks to <12 months at Penta-1, then at Penta-3", "placebo_ages": null, "frequency": "two doses, at Penta-1 and Penta-3 visits", "rounds": 2, "dose": "20 mg/kg (max 1 g)" }, { "label": "Infant-only cohort, placebo", "azithromycin_ages": null, "placebo_ages": "infants 6 weeks to <12 months at Penta-1, then at Penta-3", "frequency": "two doses, at Penta-1 and Penta-3 visits", "rounds": 2, "dose": null } ], "control": "placebo", "masking": "double", "strategy": "individual_infant", "comparisons": [ { "treated_arm": "Maternal AZ, infant AZ + Maternal placebo, infant AZ + Infant-only cohort, AZ", "control_arm": "Maternal AZ, infant placebo + Maternal placebo, infant placebo + Infant-only cohort, placebo", "strategy": "individual_infant" } ], "mortality_outcome": { "ages": "infants from the first infant dose (>= 6 weeks) through 6-12 months", "ascertainment": "follow_up_visit", "primary": true, "description": "Co-primary aim 1B: infant mortality from the first infant dose through 6-12 months of age, with vital status assessed at study visits (6 and 12 months, and a final assessment when the last infant reaches 6 months). Aim 1A (maternal factor): composite of stillbirth and infant death." }, "co_interventions": [ "seasonal malaria chemoprevention (SP+AQ monthly July-October, children 3-59 months; standard of care)", "intermittent preventive treatment in pregnancy with SP (standard of care)" ], "registration": [ "NCT03909737" ], "notes": "A 2x2 factorial in a rural mother-infant cohort (maternal 2 g azithromycin at up to two antenatal visits and delivery vs placebo; infant azithromycin at Penta-1 and Penta-3 vs placebo) plus a 1:1 infant-only cohort; the infant comparison (aim 1B) pools both cohorts across maternal arms, which the factorial balances, and the maternal comparison (aim 1A, stillbirth plus infant death) is not listed because it doses pregnant women, not children. The registry also describes an urban Bamako cohort randomized mother and infant in tandem that the protocol does not mention; planned 49,600 pregnant participants and 12,000 infant-only participants, actual counts not given.", "third_reader_reason": "Listed only the infant comparison (co-primary aim 1B), pooled across maternal arms and the infant-only cohort as the protocol analyzes it, as individual_infant; the maternal comparison (aim 1A) gives azithromycin to pregnant women rather than children, so it is not a comparison of azithromycin to children and stays in the arms and notes. Took coder 2's six arms, which the text describes, so maternal azithromycin, a randomized factor that not every arm got, is not a co-intervention." } ]