[
  {
    "trial": "T01",
    "eligible": true,
    "exclusion_reason": null,
    "unit": "community",
    "units": null,
    "countries": ["Malawi", "Niger", "Tanzania"],
    "period": {"start": "2014-12", "end": "2018-09"},
    "arms": [
      {"label": "Azithromycin", "azithromycin_ages": "1-59 months", "placebo_ages": null, "frequency": "biannual", "rounds": 4, "dose": "at least 20 mg/kg"},
      {"label": "Placebo", "azithromycin_ages": null, "placebo_ages": "1-59 months", "frequency": "biannual", "rounds": 4, "dose": null}
    ],
    "control": "placebo",
    "masking": "double",
    "strategy": "all_children_mda",
    "comparisons": [
      {"treated_arm": "Azithromycin", "control_arm": "Placebo", "strategy": "all_children_mda"}
    ],
    "mortality_outcome": {
      "ages": "1-59 months",
      "ascertainment": "census",
      "primary": true,
      "description": "Community-level all-cause mortality rate among children 1-59 months from a biannual house-to-house census over 24 months, aggregated across the three countries; a death counted when a child alive in the household at one census was recorded as dead at the next. The Niger continuation followed mortality to 36 months."
    },
    "co_interventions": [],
    "registration": ["NCT02047981"],
    "notes": "Numbers of communities randomized are not given (620 per country was the planned sample size), and rounds follow from 'every 6 months for 2 years'. The period is the registry's start and primary completion, which include a Niger-only third year (MORDOR II) in which all communities got biannual azithromycin and the comparison became first versus third year of treatment; the registry also lists the UK and US."
  },
  {
    "trial": "T02",
    "eligible": true,
    "exclusion_reason": null,
    "unit": "community",
    "units": null,
    "countries": ["Niger"],
    "period": {"start": "2017-10", "end": "2020-07"},
    "arms": [
      {"label": "Azithro", "azithromycin_ages": "1-59 months", "placebo_ages": null, "frequency": "biannual", "rounds": 4, "dose": null},
      {"label": "Placebo", "azithromycin_ages": null, "placebo_ages": "1-59 months", "frequency": "biannual", "rounds": 4, "dose": null}
    ],
    "control": "placebo",
    "masking": "unclear",
    "strategy": "all_children_mda",
    "comparisons": [
      {"treated_arm": "Azithro", "control_arm": "Placebo", "strategy": "all_children_mda"}
    ],
    "mortality_outcome": {
      "ages": "1-59 months",
      "ascertainment": "census",
      "primary": true,
      "description": "All-cause mortality rate in children 1-59 months by biannual census (present on one census and absent from the next because of death), compared between the re-randomized groups over the 24 months of rounds 7-10."
    },
    "co_interventions": [],
    "registration": ["NCT03338244"],
    "notes": "Registry text only. All Niger MORDOR communities (NCT02047981), after 2 years of azithromycin or placebo and a third year of azithromycin for all, were re-randomized to 2 more years of biannual azithromycin or placebo, so both arms had prior azithromycin. Masking is listed as NONE although the control got placebo; dose and numbers of communities are not stated; the registry also lists the US."
  },
  {
    "trial": "T03",
    "eligible": true,
    "exclusion_reason": null,
    "unit": "community",
    "units": null,
    "countries": ["Niger"],
    "period": {"start": "2020-11", "end": "2024-07"},
    "arms": [
      {"label": "Azithro 1-11", "azithromycin_ages": "1-11 months", "placebo_ages": "12-59 months", "frequency": "biannual", "rounds": 4, "dose": "20 mg/kg (up to the maximum adult dose of 1 g)"},
      {"label": "Azithro 1-59", "azithromycin_ages": "1-59 months", "placebo_ages": null, "frequency": "biannual", "rounds": 4, "dose": "20 mg/kg (up to the maximum adult dose of 1 g)"},
      {"label": "Placebo", "azithromycin_ages": null, "placebo_ages": "1-59 months", "frequency": "biannual", "rounds": 4, "dose": null}
    ],
    "control": "placebo",
    "masking": "double",
    "strategy": "all_children_mda",
    "comparisons": [
      {"treated_arm": "Azithro 1-59", "control_arm": "Placebo", "strategy": "all_children_mda"},
      {"treated_arm": "Azithro 1-11", "control_arm": "Placebo", "strategy": "infant_only_mda"},
      {"treated_arm": "Azithro 1-59", "control_arm": "Azithro 1-11", "strategy": "schedule_comparison"}
    ],
    "mortality_outcome": {
      "ages": "1-59 months (with 1-11 and 12-59 months as separate primary outcomes)",
      "ascertainment": "census",
      "primary": true,
      "description": "Three hierarchically tested primary community-level mortality rates (deaths per 1000 person-years) from a door-to-door census every 6 months: 1-59 months (Azithro 1-59 vs Placebo), 1-11 months (Azithro 1-11 vs Placebo), and 12-59 months (Azithro 1-11 vs Azithro 1-59), assessed at 2.5 years from first enrollment (the abstract says mortality was monitored twice yearly over 2 years)."
    },
    "co_interventions": [
      "seasonal malaria chemoprevention where present (background programme, prespecified subgroup)",
      "trachoma-programme azithromycin distribution where present (background, prespecified subgroup)"
    ],
    "registration": ["NCT04224987"],
    "notes": "Response-adaptive allocation after a 1:1:1 run-in year, each community keeping its allocation for 4 distributions; the top-level strategy is that of the first of the three hierarchical comparisons. Planned 3350 communities (about 1116 per arm), actual numbers not given; an 80-community open-label substudy (azithromycin 1-11 vs 1-59 months, no placebo, cost outcomes) is not coded."
  },
  {
    "trial": "T04",
    "eligible": true,
    "exclusion_reason": null,
    "unit": "community",
    "units": null,
    "countries": ["Burkina Faso"],
    "period": {"start": "2019-08", "end": "2023-02"},
    "arms": [
      {"label": "Biannual mass oral azithromycin", "azithromycin_ages": "1-59 months", "placebo_ages": null, "frequency": "biannual", "rounds": 6, "dose": "20 mg/kg"},
      {"label": "Biannual mass oral placebo", "azithromycin_ages": null, "placebo_ages": "1-59 months", "frequency": "biannual", "rounds": 6, "dose": null}
    ],
    "control": "placebo",
    "masking": "double",
    "strategy": "all_children_mda",
    "comparisons": [
      {"treated_arm": "Biannual mass oral azithromycin", "control_arm": "Biannual mass oral placebo", "strategy": "all_children_mda"}
    ],
    "mortality_outcome": {
      "ages": "1-59 months",
      "ascertainment": "census",
      "primary": true,
      "description": "Cluster-level all-cause mortality rate among children 1-59 months from a twice-yearly door-to-door census (6 rounds of census and treatment, August 2019 to July 2022, final census August 2022 to February 2023); a death counted if a child alive at one census died before the next."
    },
    "co_interventions": [
      "seasonal malaria chemoprevention (SP+AQ, 4 monthly rounds July-October, children 3-59 months)",
      "nested factorial trial: single-dose azithromycin or placebo to infants 5-12 weeks at well-child visits (both arms)"
    ],
    "registration": ["NCT03676764"],
    "notes": "Community trial of CHAT; its nested individually randomized infant trial shares this registration and protocol, is reported separately, and is coded as T05. The registry says 278 communities while the protocol and report give 341 (48 HDSS, 293 non-HDSS; '170 and 171 per arm' without saying which), so units is null; some communities left or re-entered because of insecurity."
  },
  {
    "trial": "T05",
    "eligible": true,
    "exclusion_reason": null,
    "unit": "individual",
    "units": null,
    "countries": ["Burkina Faso"],
    "period": {"start": "2019-08", "end": "2023-12"},
    "arms": [
      {"label": "Targeted oral azithromycin", "azithromycin_ages": "infants 5-12 weeks at a well-child visit", "placebo_ages": null, "frequency": "single", "rounds": 1, "dose": "20 mg/kg"},
      {"label": "Targeted oral placebo", "azithromycin_ages": null, "placebo_ages": "infants 5-12 weeks at a well-child visit", "frequency": "single", "rounds": 1, "dose": null}
    ],
    "control": "placebo",
    "masking": "double",
    "strategy": "individual_infant",
    "comparisons": [
      {"treated_arm": "Targeted oral azithromycin", "control_arm": "Targeted oral placebo", "strategy": "individual_infant"}
    ],
    "mortality_outcome": {
      "ages": "infants to 6 months of age (enrolled at 5-12 weeks)",
      "ascertainment": "follow_up_visit",
      "primary": true,
      "description": "Death before 6 months of age; vital status assessed at a 180-day (6-month) visit at the health facility, with a home visit if the caregiver did not attend."
    },
    "co_interventions": [
      "CHAT community trial: biannual mass azithromycin or placebo to children 1-59 months, for infants living in its Nouna District communities (factorial)"
    ],
    "registration": ["NCT03676764"],
    "notes": "Individually randomized infant trial of CHAT, sharing its registration and protocol with the community trial (T04). The protocol recruits at Nouna District health centres from 28 to 84 days of age, while the report says 5-12 weeks in three regions of Burkina Faso; the period is the shared registry dates; planned 32,702 infants (16,351 per arm)."
  },
  {
    "trial": "T06",
    "eligible": true,
    "exclusion_reason": null,
    "unit": "individual",
    "units": null,
    "countries": ["Burkina Faso"],
    "period": {"start": "2019-04", "end": "2022-05"},
    "arms": [
      {"label": "Azithromycin", "azithromycin_ages": "neonates 8-27 days", "placebo_ages": null, "frequency": "single", "rounds": 1, "dose": "20 mg/kg"},
      {"label": "Placebo", "azithromycin_ages": null, "placebo_ages": "neonates 8-27 days", "frequency": "single", "rounds": 1, "dose": null}
    ],
    "control": "placebo",
    "masking": "double",
    "strategy": "individual_infant",
    "comparisons": [
      {"treated_arm": "Azithromycin", "control_arm": "Placebo", "strategy": "individual_infant"}
    ],
    "mortality_outcome": {
      "ages": "infants to 6 months of age (enrolled at 8-27 days)",
      "ascertainment": "follow_up_visit",
      "primary": true,
      "description": "All-cause mortality by 6 months of age, from vital status recorded at study visits (21 days after enrollment, and 3 and 6 months of age; 6-month window age 141-225 days); neonatal (<28 days) and 12-month mortality are secondary."
    },
    "co_interventions": [
      "seasonal malaria chemoprevention for children 3-59 months, monthly July-October (background programme)"
    ],
    "registration": ["NCT03682653"],
    "notes": "Recruited at facility births and BCG vaccination days; neonates under 2500 g, jaundiced, unable to feed orally, or living in communities of the CHAT/CHATON community trial were excluded. The report says 44 facilities in 5 regions while the protocol says nine regions; planned 10,856 per arm."
  },
  {
    "trial": "T07",
    "eligible": true,
    "exclusion_reason": null,
    "unit": "community",
    "units": null,
    "countries": ["Mali"],
    "period": {"start": "2020-10", "end": "2024-12"},
    "arms": [
      {"label": "Control", "azithromycin_ages": null, "placebo_ages": "1-11 months (29-364 days)", "frequency": "quarterly", "rounds": 8, "dose": null},
      {"label": "Azi-biannual", "azithromycin_ages": "1-11 months (29-364 days)", "placebo_ages": "1-11 months (29-364 days)", "frequency": "biannual (azithromycin at the two quarterly visits January-June, placebo at the two July-December)", "rounds": 4, "dose": "20 mg/kg"},
      {"label": "Azi-quarterly", "azithromycin_ages": "1-11 months (29-364 days)", "placebo_ages": null, "frequency": "quarterly", "rounds": 8, "dose": "20 mg/kg"}
    ],
    "control": "placebo",
    "masking": "double",
    "strategy": "infant_only_mda",
    "comparisons": [
      {"treated_arm": "Azi-biannual", "control_arm": "Control", "strategy": "infant_only_mda"},
      {"treated_arm": "Azi-quarterly", "control_arm": "Control", "strategy": "infant_only_mda"},
      {"treated_arm": "Azi-quarterly", "control_arm": "Azi-biannual", "strategy": "schedule_comparison"}
    ],
    "mortality_outcome": {
      "ages": "1-11 months (29-364 days) at an MDA, followed to the next quarterly visit",
      "ascertainment": "census",
      "primary": true,
      "description": "All-cause mortality (deaths per 1000 person-years) among infants 1-11 months old at an MDA, over the 3-month interval to the next quarterly house-to-house census visit, each infant contributing 1-4 intervals; mortality of children 12-59 months at the latest MDA is secondary."
    },
    "co_interventions": [
      "national seasonal malaria chemoprevention (SP+AQ monthly July-October, children 3-59 months)"
    ],
    "registration": ["NCT04424511"],
    "notes": "Villages randomized 3:4:2 (control, biannual, quarterly) with an adaptive design under which the interim analysis could drop placebo; older children were not treated. Rounds are per village over 24 months (4 of the biannual arm's 8 visits gave azithromycin, the other 4 placebo, to avoid the SMC season); staggered entry meant 6-8 MDA visits and each infant got at most 4 doses; 1151 villages in all, per-arm numbers not given."
  },
  {
    "trial": "T08",
    "eligible": true,
    "exclusion_reason": null,
    "unit": "community",
    "units": null,
    "countries": ["Burkina Faso"],
    "period": {"start": "2021-09", "end": "2024-01"},
    "arms": [
      {"label": "Biannual mass oral azithromycin (child health days)", "azithromycin_ages": "1-11 months", "placebo_ages": null, "frequency": "biannual", "rounds": null, "dose": "by age under 6 months and by height from 6 months (mg/kg not stated)"},
      {"label": "Biannual mass placebo (child health days)", "azithromycin_ages": null, "placebo_ages": "1-11 months", "frequency": "biannual", "rounds": null, "dose": null}
    ],
    "control": "placebo",
    "masking": "double",
    "strategy": "infant_only_mda",
    "comparisons": [
      {"treated_arm": "Biannual mass oral azithromycin (child health days)", "control_arm": "Biannual mass placebo (child health days)", "strategy": "infant_only_mda"}
    ],
    "mortality_outcome": {
      "ages": "1-11 months",
      "ascertainment": "birth_history",
      "primary": true,
      "description": "Mortality among children eligible for treatment (1-11 months) within 6 months of each MDA, per 1000 person-years at CSPS level, from a birth history of all women 15-52 years in eligible households (live births in the prior 3 years); it became primary after a masked interim analysis found low census mortality, and the biannual census rate became secondary."
    },
    "co_interventions": [
      "vitamin A supplementation (6-59 months) through Child Health Days",
      "acute malnutrition screening (6-59 months) through Child Health Days",
      "deworming (12-59 months) through Child Health Days"
    ],
    "registration": ["NCT04716712"],
    "notes": "Arm labels are the registry's with '+ child health days' put in parentheses. Randomized 2:1 by CSPS (a health-centre catchment of about five communities); planned 516 CSPSs, per-arm numbers not given, and the number of distributions is not stated (biannual over about 2 years). The registry names Centre-Ouest where the report says Centre-Est and also lists the US; a separate 60-community AMR substudy is not coded."
  },
  {
    "trial": "T09",
    "eligible": true,
    "exclusion_reason": null,
    "unit": "community",
    "units": {
      "Annual, standard coverage (80%)": 12,
      "Annual, enhanced coverage (90%)": 12,
      "Biannual, standard coverage (80%)": 12,
      "Biannual, enhanced coverage (90%)": 12
    },
    "countries": ["Niger"],
    "period": {"start": "2008-05", "end": "2013-06"},
    "arms": [
      {"label": "Annual, standard coverage (80%)", "azithromycin_ages": "all ages >= 6 months", "placebo_ages": null, "frequency": "annual", "rounds": 3, "dose": "20 mg/kg up to 1 g"},
      {"label": "Annual, enhanced coverage (90%)", "azithromycin_ages": "all ages >= 6 months", "placebo_ages": null, "frequency": "annual", "rounds": 3, "dose": "20 mg/kg up to 1 g"},
      {"label": "Biannual, standard coverage (80%)", "azithromycin_ages": "6 months-12 years", "placebo_ages": null, "frequency": "biannual", "rounds": 6, "dose": "20 mg/kg up to 1 g"},
      {"label": "Biannual, enhanced coverage (90%)", "azithromycin_ages": "6 months-12 years", "placebo_ages": null, "frequency": "biannual", "rounds": 6, "dose": "20 mg/kg up to 1 g"}
    ],
    "control": "other_schedule",
    "masking": "single",
    "strategy": "schedule_comparison",
    "comparisons": [
      {"treated_arm": "Biannual, standard coverage (80%) + Biannual, enhanced coverage (90%)", "control_arm": "Annual, standard coverage (80%) + Annual, enhanced coverage (90%)", "strategy": "schedule_comparison"}
    ],
    "mortality_outcome": {
      "ages": "6 months to <5 years",
      "ascertainment": "census",
      "primary": false,
      "description": "Community-level all-cause mortality rate in children 6 months to <5 years over the 3-year study, from vital status recorded at annual censuses, treatment visits and biannual trachoma monitoring visits by data collectors masked to arm; prespecified for this secondary analysis of a trachoma trial whose primary outcome was trachoma and ocular chlamydia."
    },
    "co_interventions": [],
    "registration": ["NCT00792922"],
    "notes": "Secondary analysis of the PRET-Niger trachoma trial, a 2x2 factorial of frequency and coverage target (12 communities per cell), with mortality compared between pooled biannual and pooled annual arms and no untreated arm: annual treated everyone >= 6 months, biannual only children 6 months-12 years, and children under 6 months or allergic got topical tetracycline. Niger dates are not given, so the period is the registry's for PRET as a whole (also run in The Gambia and Tanzania); the registry lists the UK and US."
  },
  {
    "trial": "T10",
    "eligible": true,
    "exclusion_reason": null,
    "unit": "community",
    "units": {
      "Arm A: annual, all residents": 12,
      "Arm B: biannual, all residents": 12,
      "Arm C: quarterly, children only": 12,
      "Arm D: delayed treatment": 12,
      "Arm F: one-time mass treatment": 12,
      "Arm G: one-time mass treatment plus latrines": 12
    },
    "countries": ["Ethiopia"],
    "period": {"start": "2006-05", "end": "2007-05"},
    "arms": [
      {"label": "Arm A: annual, all residents", "azithromycin_ages": "all ages >= 1 year", "placebo_ages": null, "frequency": "annual", "rounds": null, "dose": "children 20 mg/kg; adults 1 g"},
      {"label": "Arm B: biannual, all residents", "azithromycin_ages": "all ages >= 1 year", "placebo_ages": null, "frequency": "biannual", "rounds": null, "dose": "children 20 mg/kg; adults 1 g"},
      {"label": "Arm C: quarterly, children only", "azithromycin_ages": "1-9 years", "placebo_ages": null, "frequency": "quarterly", "rounds": null, "dose": "20 mg/kg"},
      {"label": "Arm D: delayed treatment", "azithromycin_ages": null, "placebo_ages": null, "frequency": null, "rounds": 0, "dose": null},
      {"label": "Arm F: one-time mass treatment", "azithromycin_ages": "all ages >= 1 year", "placebo_ages": null, "frequency": "single", "rounds": 1, "dose": "children 20 mg/kg (height-based); adults 1 g"},
      {"label": "Arm G: one-time mass treatment plus latrines", "azithromycin_ages": "all ages >= 1 year", "placebo_ages": null, "frequency": "single", "rounds": 1, "dose": "children 20 mg/kg (height-based); adults 1 g"}
    ],
    "control": "delayed_treatment",
    "masking": "single",
    "strategy": "community_wide_mda",
    "comparisons": [
      {"treated_arm": "Arm A: annual, all residents", "control_arm": "Arm D: delayed treatment", "strategy": "community_wide_mda"},
      {"treated_arm": "Arm B: biannual, all residents", "control_arm": "Arm D: delayed treatment", "strategy": "community_wide_mda"},
      {"treated_arm": "Arm C: quarterly, children only", "control_arm": "Arm D: delayed treatment", "strategy": "other"}
    ],
    "mortality_outcome": {
      "ages": "1-9 years",
      "ascertainment": "census",
      "primary": false,
      "description": "Community-specific mortality risk for children 1-9 years over 1 year (May 2006 to May 2007), by enumerative census at baseline and 12 months; a prespecified outcome of a trachoma trial whose primary outcome was ocular chlamydia (the registry lists childhood mortality as secondary). Arms F and G have only an observational treated-versus-untreated cohort analysis over 26 months (censuses May 2006 and August 2008)."
    },
    "co_interventions": [],
    "registration": ["NCT00322972"],
    "notes": "TANA randomized 72 subkebeles to 6 arms of 12; the randomized mortality comparison (treated arms pooled against delayed treatment over the first year) uses arms A-D, so no comparison is coded for F and G, which differ only by latrines. Arm C's comparison is 'other' because its band (1-9 years in the reports, 1-10 in the registry) leaves out infants and so does not cover 1-59 months; rounds within the comparison year are not stated."
  },
  {
    "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": "households in which a pre-school-aged child has clinically active trachoma (ages not stated)", "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"},
      {"treated_arm": "Arm O: targeted treatment by clinical exam", "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 by age or by clinical exam. Arm sizes, doses, the targeted arms' ages, schedules and comparators, and how mortality was ascertained are not given; pairing each continue arm with its stop arm, and the stop arms as controls for the targeted arms, is read from the arm labels and Aim 6."
  },
  {
    "trial": "T12",
    "eligible": true,
    "exclusion_reason": null,
    "unit": "household",
    "units": null,
    "countries": ["Burkina Faso", "Mali"],
    "period": {"start": "2014-08", "end": "2016-12"},
    "arms": [
      {"label": "SMC+placebo", "azithromycin_ages": null, "placebo_ages": "3-59 months", "frequency": "monthly during the malaria season (four 3-day courses a season)", "rounds": 12, "dose": null},
      {"label": "SMC+AZ", "azithromycin_ages": "3-59 months", "placebo_ages": null, "frequency": "monthly during the malaria season (four 3-day courses a season)", "rounds": 12, "dose": null}
    ],
    "control": "placebo",
    "masking": "double",
    "strategy": "individual_child",
    "comparisons": [
      {"treated_arm": "SMC+AZ", "control_arm": "SMC+placebo", "strategy": "individual_child"}
    ],
    "mortality_outcome": {
      "ages": "3-59 months",
      "ascertainment": "other",
      "primary": false,
      "description": "Deaths recorded by active and passive surveillance at hospitals and health facilities, with verbal autopsy for deaths outside facilities; death is part of the composite primary endpoint (death or hospital admission for at least 24 hours not due to trauma or elective surgery) during each intervention period (first SMC dose to 30 days after the last course each year)."
    },
    "co_interventions": [
      "seasonal malaria chemoprevention with SP+AQ, four monthly 3-day courses a season (both arms)"
    ],
    "registration": ["NCT02211729"],
    "notes": "Household-randomized; azithromycin (dose not stated) or placebo was added to each SMC course for three seasons, and mortality is reported only within a composite primary endpoint. Newly eligible children joined each year and children stopped at 5 years; planned 19,200 children (30,977 contributed person-time); HIV-positive children on cotrimoxazole were excluded."
  },
  {
    "trial": "T13",
    "eligible": true,
    "exclusion_reason": null,
    "unit": "individual",
    "units": null,
    "countries": ["Sierra Leone"],
    "period": {"start": "2021-03", "end": "2025-09"},
    "arms": [
      {"label": "Group 1 (azithromycin)", "azithromycin_ages": "6 weeks, 9 months and 15 months (at EPI visits)", "placebo_ages": null, "frequency": "three EPI contacts (6 weeks, 9 months, 15 months)", "rounds": 3, "dose": "20 mg/kg"},
      {"label": "Group 2 (placebo)", "azithromycin_ages": null, "placebo_ages": "6 weeks, 9 months and 15 months (at EPI visits)", "frequency": "three EPI contacts (6 weeks, 9 months, 15 months)", "rounds": 3, "dose": null}
    ],
    "control": "placebo",
    "masking": "double",
    "strategy": "individual_infant",
    "comparisons": [
      {"treated_arm": "Group 1 (azithromycin)", "control_arm": "Group 2 (placebo)", "strategy": "individual_infant"}
    ],
    "mortality_outcome": {
      "ages": "from enrollment (6-10 weeks) to 18 months of age",
      "ascertainment": "other",
      "primary": true,
      "description": "All-cause mortality rate to 18 months of age, captured by a Demographic Surveillance System in each health-facility catchment area with passive and active case detection and an end-of-trial visit at 18 months; verbal autopsy for deaths in the community."
    },
    "co_interventions": [
      "perennial malaria chemoprevention (IPTi) with SP at 10 and 14 weeks and 6, 9, 12 and 15 months (both arms)"
    ],
    "registration": ["NCT04235816"],
    "notes": "Azithromycin was given with vaccines at three EPI contacts, the last (15 months) after infancy; both arms also got SP chemoprevention, including added doses whose effect is assessed only against a non-randomized cohort. The registry mentions a factorial design and enrollment at 6-8 weeks, while the protocol has two arms and enrollment up to 10 weeks (>= 2.5 kg); planned 10,280 per arm."
  },
  {
    "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"},
      {"treated_arm": "Maternal AZ, infant AZ + Maternal AZ, infant placebo", "control_arm": "Maternal placebo, infant AZ + Maternal placebo, infant placebo", "strategy": "other"}
    ],
    "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 the mother-infant cohort (maternal 2 g azithromycin at antenatal care 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, and the maternal comparison is 'other' since it doses pregnant women, not children. The registry also describes an urban Bamako cohort that the protocol does not mention; planned 49,600 pregnant participants and 12,000 infant-only participants."
  },
  {
    "trial": "T15",
    "eligible": false,
    "exclusion_reason": "Not population-scale delivery: a growth trial in an enrolled cohort of 1,188 newborns (<= 14 days old, mothers >= 18, breastfed, birth weight >= 1500 g), not every child of a community or every infant a programme or visit reaches; azithromycin is also given only together with nitazoxanide.",
    "unit": "individual",
    "units": null,
    "countries": ["Tanzania"],
    "period": {"start": "2017-09", "end": "2020-02"},
    "arms": [
      {"label": "Nicotinamide and Antimicrobials", "azithromycin_ages": "infants enrolled at 0-14 days (dosing ages not stated)", "placebo_ages": null, "frequency": "scheduled (schedule not stated)", "rounds": null, "dose": null},
      {"label": "Antimicrobials only", "azithromycin_ages": "infants enrolled at 0-14 days (dosing ages not stated)", "placebo_ages": null, "frequency": "scheduled (schedule not stated)", "rounds": null, "dose": null},
      {"label": "Nicotinamide only", "azithromycin_ages": null, "placebo_ages": "infants enrolled at 0-14 days (dosing ages not stated)", "frequency": "scheduled (schedule not stated)", "rounds": null, "dose": null},
      {"label": "No active treatment", "azithromycin_ages": null, "placebo_ages": "infants enrolled at 0-14 days (dosing ages not stated)", "frequency": "scheduled (schedule not stated)", "rounds": null, "dose": null}
    ],
    "control": "placebo",
    "masking": "double",
    "strategy": "other",
    "comparisons": [
      {"treated_arm": "Nicotinamide and Antimicrobials + Antimicrobials only", "control_arm": "Nicotinamide only + No active treatment", "strategy": "other"}
    ],
    "mortality_outcome": {
      "ages": "0-18 months",
      "ascertainment": null,
      "primary": false,
      "description": "All-cause mortality from 0 to 18 months, a registered secondary outcome of a growth trial (primary: height-for-age z-score at 18 months); how deaths were ascertained is not described."
    },
    "co_interventions": [],
    "registration": ["NCT03268902"],
    "notes": "Registry text and the main report's background only: a 2x2 factorial of daily nicotinamide and scheduled antimicrobials (azithromycin with nitazoxanide); the timing, number and dose of azithromycin are not stated. The antimicrobial comparison is 'other' because azithromycin comes with nitazoxanide in a research cohort; the nicotinamide comparison is not coded."
  },
  {
    "trial": "T16",
    "eligible": false,
    "exclusion_reason": "Not population-scale delivery: a growth and gut-microbiome trial that gave one dose to a fixed sample (planned 225 per arm) of children 8 days-59 months whose caregivers chose to enroll at the district hospital after household visits in Nouna town, not to every child of an age band or every child a programme or visit reaches.",
    "unit": "individual",
    "units": null,
    "countries": ["Burkina Faso"],
    "period": {"start": "2019-11", "end": "2020-06"},
    "arms": [
      {"label": "Azithromycin", "azithromycin_ages": "8 days-59 months", "placebo_ages": null, "frequency": "single", "rounds": 1, "dose": "20 mg/kg (by weight under 12 months, height stick from 12 months)"},
      {"label": "Placebo", "azithromycin_ages": null, "placebo_ages": "8 days-59 months", "frequency": "single", "rounds": 1, "dose": null}
    ],
    "control": "placebo",
    "masking": "double",
    "strategy": "other",
    "comparisons": [
      {"treated_arm": "Azithromycin", "control_arm": "Placebo", "strategy": "other"}
    ],
    "mortality_outcome": {
      "ages": "8 days-59 months at enrollment",
      "ascertainment": "follow_up_visit",
      "primary": false,
      "description": "Death within the 180-day study period, from vital status assessed at follow-up visits (14 days and 6 months); a registered secondary outcome that the report's Methods do not mention."
    },
    "co_interventions": [],
    "registration": ["NCT03676751"],
    "notes": "Mechanistic trial run alongside the community trial in Nouna town, with gut-microbiome diversity, macrolide resistance and weight gain as primary outcomes; strategy is 'other' because the single dose is not delivered through a programme. Planned 225 per arm (registry enrollment 500)."
  }
]