[
  {
    "trial": "T01",
    "eligible": true,
    "exclusion_reason": null,
    "unit": "community",
    "units": null,
    "countries": ["Malawi", "Niger", "Tanzania"],
    "period": {"start": "2014-12", "end": "2018-09"},
    "arms": [
      {"label": "Biannual mass oral azithromycin", "azithromycin_ages": "1-59 months", "placebo_ages": null, "frequency": "biannual", "rounds": 4, "dose": "at least 20 mg/kg oral suspension, by height stick or by weight for those unable to stand"},
      {"label": "Biannual mass oral 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": "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": "Community-level all-cause mortality rate among children 1-59 months, pooled over the three countries, from a biannual house-to-house census over 24 months (alive at one census, died in the community by the next; movers not traced). In Niger a prespecified continuation followed mortality to 36 months."},
    "co_interventions": [],
    "registration": ["NCT02047981"],
    "notes": "MORDOR: per-arm community counts are not given (620 per country planned), and the period is the registration's start and primary completion, which spans Niger's third year; the registration also lists the UK and US among countries. In Niger every community then got azithromycin for a third year (2 more biannual rounds, so 6 azithromycin rounds in the azithromycin arm and 4 placebo then 2 azithromycin in the placebo arm), compared as a third vs a first year of azithromycin and not coded as a separate comparison."
  },
  {
    "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 among children 1-59 months (registered as 1-60 months, up to the 5th birthday) by biannual census (present on one census, absent on the next because of death), compared between the re-randomized arms over the 24 months after re-randomization."},
    "co_interventions": [],
    "registration": ["NCT03338244"],
    "notes": "Registration only: re-randomizes the communities of MORDOR's Niger site (NCT02047981) for years 4-5, after 2 years of biannual azithromycin or placebo and a third year of azithromycin for all, giving four histories (AAAAA, AAAPP, PPAAA, PPAPP). Masking is recorded as NONE although the control gets placebo, hence unclear; dose and per-arm counts are not stated."
  },
  {
    "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 1 g) oral suspension, by weight (1-11 months and those unable to stand) or height"},
      {"label": "Azithro 1-59", "azithromycin_ages": "1-59 months", "placebo_ages": null, "frequency": "biannual", "rounds": 4, "dose": "20 mg/kg (up to 1 g) oral suspension, by weight or height (age-based in some communities)"},
      {"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; 1-11 months; 12-59 months (one per primary comparison)", "ascertainment": "census", "primary": true, "description": "Three primary community-level all-cause mortality rates (deaths per 1000 person-years) from a door-to-door census every 6 months, tested in a fixed sequence: 1-59 months, Azithro 1-59 vs Placebo; 1-11 months, Azithro 1-11 vs Placebo; 12-59 months, Azithro 1-59 vs Azithro 1-11. Planned at 2.5 years from first enrolment; the main report describes twice-yearly monitoring over 2 years."},
    "co_interventions": [],
    "registration": ["NCT04224987"],
    "notes": "AVENIR: response-adaptive allocation after a one-year 1:1:1 run-in in Dosso, so arm sizes are neither fixed nor given (planned 3,350 communities, 1,116 per arm; registration 3,000), and the top-level strategy is the first of three primary comparisons, each in its own age band. A separate 80-community open-label substudy on costs is not coded, seasonal malaria chemoprevention and trachoma MDA appear only as possible effect modifiers, and the period is the registration's."
  },
  {
    "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 oral suspension, by weight (1-11 months) or height stick (12-59 months)"},
      {"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 the twice-yearly door-to-door census (alive at one census, died before the next), over six treatment rounds from August 2019 to July 2022 and a final census from August 2022 to February 2023."},
    "co_interventions": ["seasonal malaria chemoprevention (SP plus amodiaquine), 4 monthly rounds July-October, children 3-59 months", "nested individually randomized single dose of azithromycin or placebo at 5-12 weeks (factorial)"],
    "registration": ["NCT03676764"],
    "notes": "CHAT community trial: 341 communities randomized 1:1, stratified by HDSS (48) or not (293), with per-arm counts not given by arm (protocol: 170 and 171; registration: 278 communities). The same registration and protocol hold a nested individually randomized infant trial, not coded as an arm here; communities lost to insecurity could re-enter at a later census."
  },
  {
    "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", "placebo_ages": null, "frequency": "single", "rounds": 1, "dose": "20 mg/kg"},
      {"label": "Targeted oral placebo", "azithromycin_ages": null, "placebo_ages": "infants 5-12 weeks", "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": "5-12 weeks at treatment to 6 months of age", "ascertainment": "follow_up_visit", "primary": true, "description": "Death before 6 months of age, vital status assessed at a 6-month (180-day) follow-up visit at the clinic or, failing that, at home."},
    "co_interventions": ["biannual mass azithromycin or placebo to children 1-59 months in the CHAT community trial (factorial, for infants living in its communities)"],
    "registration": ["NCT03676764"],
    "notes": "CHAT infant trial, sharing its registration and protocol with the CHAT community trial; the abstract says infants were recruited at well-child visits and by outreach in three regions of Burkina Faso, while the protocol describes Nouna District. Planned 32,702 infants (16,351 per arm) with actual counts not given, and the period end is the shared registration's primary completion."
  },
  {
    "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": "8-27 days at treatment to 6 months of age", "ascertainment": "follow_up_visit", "primary": true, "description": "All-cause mortality by 6 months of age, vital status recorded at study visits (21 days after enrolment, 3 and 6 months of age; 6-month window plus or minus 6 weeks). Mortality before 28 days and at 12 months are secondary."},
    "co_interventions": ["seasonal malaria chemoprevention, monthly July-October, children 3-59 months (background programme)"],
    "registration": ["NCT03682653"],
    "notes": "NAITRE: neonates of at least 2500 g recruited at facility births and BCG vaccination days in 44 facilities, excluding infants living in CHAT community-trial communities; planned 21,712 (10,856 per arm), actual per-arm counts not given. The period is the registration's; follow-up continued to 12 months of age."
  },
  {
    "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": "Azithromycin-biannually", "azithromycin_ages": "1-11 months (29-364 days)", "placebo_ages": "1-11 months (29-364 days), at the July-December visits", "frequency": "biannual (azithromycin at the two quarterly visits January-June, placebo at the two July-December visits)", "rounds": 4, "dose": "20 mg/kg (0.5 ml/kg of a 40 mg/ml suspension), by weight"},
      {"label": "Azithromycin-quarterly", "azithromycin_ages": "1-11 months (29-364 days)", "placebo_ages": null, "frequency": "quarterly", "rounds": 8, "dose": "20 mg/kg (0.5 ml/kg of a 40 mg/ml suspension), by weight"}
    ],
    "control": "placebo",
    "masking": "double",
    "strategy": "infant_only_mda",
    "comparisons": [
      {"treated_arm": "Azithromycin-biannually", "control_arm": "Control", "strategy": "infant_only_mda"},
      {"treated_arm": "Azithromycin-quarterly", "control_arm": "Control", "strategy": "infant_only_mda"},
      {"treated_arm": "Azithromycin-quarterly", "control_arm": "Azithromycin-biannually", "strategy": "schedule_comparison"}
    ],
    "mortality_outcome": {"ages": "1-11 months (29-364 days) at an MDA visit, followed to the next quarterly visit", "ascertainment": "census", "primary": true, "description": "Deaths per 1000 person-years among infants 1-11 months old at an MDA visit, over the 3-month interval to the next quarterly house-to-house census, across up to 8 intervals in 24 months (each infant contributing 1-4). Mortality among children 12-59 months at the latest MDA is secondary."},
    "co_interventions": ["seasonal malaria chemoprevention (SP plus amodiaquine), monthly July-October, children 3-59 months (national programme)"],
    "registration": ["NCT04424511"],
    "notes": "LAKANA: villages randomized 3:4:2 (control, biannual, quarterly), 1,151 in all, with per-arm counts not given; rounds are per village (8 quarterly visits planned over 24 months, 6-8 with staggered entry), each infant getting at most 4 doses. The design was adaptive (an interim analysis could drop placebo and re-randomize its villages), and the top-level strategy is that of both comparisons with control."
  },
  {
    "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": "oral suspension dosed by age (under 6 months) or height (6 months and older)"},
      {"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": "Deaths per 1000 person-years among children 1-11 months within 6 months of a community's MDA, by CSPS, from a birth history of women 15-52 years (live births in the previous 3 years), made the primary endpoint after a masked interim analysis found lower-than-expected census mortality; mortality from the biannual census is secondary."},
    "co_interventions": ["vitamin A supplementation, children 6-59 months (Child Health Days)", "acute malnutrition screening, children 6-59 months (Child Health Days)", "deworming with albendazole or mebendazole, children 12-59 months (Child Health Days)"],
    "registration": ["NCT04716712"],
    "notes": "MIRAMA: CSPS catchment areas randomized 2:1, with per-arm counts and the number of distributions not given (planning assumed 516 CSPSs, biannually over a 2-year trial); the primary endpoint moved from census to birth history after a masked interim analysis. A separate 60-community resistance substudy is not coded, the registration names Centre-Ouest where the report names Centre-Est, and the dates are the report's (registration 2021-10 to 2025-01)."
  },
  {
    "trial": "T09",
    "eligible": true,
    "exclusion_reason": null,
    "unit": "community",
    "units": {"annual": 24, "biannual": 24},
    "countries": ["Niger"],
    "period": {"start": "2008-05", "end": "2013-06"},
    "arms": [
      {"label": "annual", "azithromycin_ages": "all ages >= 6 months", "placebo_ages": null, "frequency": "annual", "rounds": 3, "dose": "20 mg/kg (up to 1 g)"},
      {"label": "biannual", "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", "control_arm": "annual", "strategy": "schedule_comparison"}
    ],
    "mortality_outcome": {"ages": "6-59 months", "ascertainment": "census", "primary": false, "description": "Community-level all-cause mortality among children 6 months to under 5 years over the 3-year study, from the annual census with vital status also recorded at treatment and biannual trachoma visits by masked data collectors; prespecified for this secondary analysis, the trial's primary outcome being trachoma and ocular chlamydia."},
    "co_interventions": [],
    "registration": ["NCT00792922"],
    "notes": "PRET-Niger: a 2x2 factorial of frequency by coverage target (80% vs 90%), 12 communities per cell, coded as the two frequency arms pooled over coverage as the report compares them; the arms differ in age band as well as frequency, and children under 6 months and those allergic got topical tetracycline in both. The registration's dates and countries (UK, US) cover PRET in Niger, The Gambia and Tanzania; Niger's 3-year period is not dated."
  },
  {
    "trial": "T10",
    "eligible": true,
    "exclusion_reason": null,
    "unit": "community",
    "units": {"A: annual mass treatment": 12, "B: biannual mass treatment": 12, "C: quarterly treatment of children": 12, "D: delayed treatment": 12, "F: single mass treatment": 12, "G: single mass treatment plus latrines": 12},
    "countries": ["Ethiopia"],
    "period": {"start": "2006-05", "end": "2007-05"},
    "arms": [
      {"label": "A: annual mass treatment", "azithromycin_ages": "all ages >= 1 year", "placebo_ages": null, "frequency": "annual", "rounds": 1, "dose": "20 mg/kg for children, 1 g for adults"},
      {"label": "B: biannual mass treatment", "azithromycin_ages": "all ages >= 1 year", "placebo_ages": null, "frequency": "biannual", "rounds": 2, "dose": "20 mg/kg for children, 1 g for adults"},
      {"label": "C: quarterly treatment of children", "azithromycin_ages": "1-9 years (registration: 1-10 years)", "placebo_ages": null, "frequency": "quarterly", "rounds": 4, "dose": "20 mg/kg"},
      {"label": "D: delayed treatment", "azithromycin_ages": null, "placebo_ages": null, "frequency": "none during the first year (treatment delayed 1 year)", "rounds": 0, "dose": null},
      {"label": "F: single mass treatment", "azithromycin_ages": "all ages >= 1 year", "placebo_ages": null, "frequency": "single", "rounds": 1, "dose": "20 mg/kg for children (by height), 1 g for adults"},
      {"label": "G: single mass treatment plus latrines", "azithromycin_ages": "all ages >= 1 year", "placebo_ages": null, "frequency": "single", "rounds": 1, "dose": "20 mg/kg for children (by height), 1 g for adults"}
    ],
    "control": "delayed_treatment",
    "masking": "single",
    "strategy": "community_wide_mda",
    "comparisons": [
      {"treated_arm": "A: annual mass treatment", "control_arm": "D: delayed treatment", "strategy": "community_wide_mda"},
      {"treated_arm": "B: biannual mass treatment", "control_arm": "D: delayed treatment", "strategy": "community_wide_mda"},
      {"treated_arm": "C: quarterly treatment of children", "control_arm": "D: delayed treatment", "strategy": "other"}
    ],
    "mortality_outcome": {"ages": "1-9 years", "ascertainment": "census", "primary": false, "description": "Community-specific mortality risk among children 1-9 years over 1 year (May 2006 to May 2007), from enumerative censuses at baseline and 12 months; a prespecified outcome of the trachoma trial, registered as secondary, whose primary outcome was ocular chlamydia."},
    "co_interventions": [],
    "registration": ["NCT00322972"],
    "notes": "TANA: 72 subkebeles in six arms; the randomized mortality comparison is A, B and C against D over the first year only, before D was treated, so rounds are those in that year, and arms F and G (one mass treatment, G with latrines) have only an observational cohort analysis of mortality to August 2008, so are not compared. C vs D is coded other because C's band starts at 1 year and leaves out infants, and the top-level strategy is that of A and B."
  },
  {
    "trial": "T11",
    "eligible": true,
    "exclusion_reason": null,
    "unit": "community",
    "units": null,
    "countries": ["Ethiopia"],
    "period": {"start": "2010-11", "end": "2013-11"},
    "arms": [
      {"label": "J: stop annual treatment", "azithromycin_ages": null, "placebo_ages": null, "frequency": "none (previous annual treatment stopped)", "rounds": 0, "dose": null},
      {"label": "K: stop biannual treatment", "azithromycin_ages": null, "placebo_ages": null, "frequency": "none (previous biannual treatment stopped)", "rounds": 0, "dose": null},
      {"label": "L: continue annual treatment", "azithromycin_ages": "all ages >= 6 months", "placebo_ages": null, "frequency": "annual", "rounds": null, "dose": null},
      {"label": "M: continue biannual treatment", "azithromycin_ages": "all ages >= 6 months", "placebo_ages": null, "frequency": "biannual", "rounds": null, "dose": null},
      {"label": "N: targeted treatment by age", "azithromycin_ages": "pre-school aged children (band not stated)", "placebo_ages": null, "frequency": null, "rounds": null, "dose": null},
      {"label": "O: targeted treatment by clinical exam", "azithromycin_ages": "households in which a pre-school child has clinically active trachoma", "placebo_ages": null, "frequency": null, "rounds": null, "dose": null}
    ],
    "control": "no_treatment",
    "masking": "single",
    "strategy": "community_wide_mda",
    "comparisons": [
      {"treated_arm": "L: continue annual treatment", "control_arm": "J: stop annual treatment", "strategy": "community_wide_mda"},
      {"treated_arm": "M: continue biannual treatment", "control_arm": "K: stop biannual treatment", "strategy": "community_wide_mda"}
    ],
    "mortality_outcome": {"ages": "6 months-5 years (also 6-10 and over 10 years)", "ascertainment": null, "primary": false, "description": "Childhood mortality at 36 months, a secondary outcome; Specific Aim 6 asks whether under-5 mortality is lower in communities treated with mass azithromycin than in untreated ones. How deaths are ascertained is not described."},
    "co_interventions": [],
    "registration": ["NCT01202331"],
    "notes": "TIRET, registration only: TANA communities with prior annual or biannual mass treatment randomized to stop, continue, or targeted treatment (primary outcome ocular chlamydia), with units, rounds, dose and N's age band not given; mass treatment excludes children under 6 months and pregnant women. Mortality comparisons are coded as continue vs stop of the same schedule since the registration doesn't say how arms are compared, and N and O (O targeting households by clinical exam) are left out."
  },
  {
    "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 plus azithromycin", "azithromycin_ages": "3-59 months", "placebo_ages": null, "frequency": "monthly in the malaria season (4 cycles a year)", "rounds": 12, "dose": null},
      {"label": "SMC plus placebo", "azithromycin_ages": null, "placebo_ages": "3-59 months", "frequency": "monthly in the malaria season (4 cycles a year)", "rounds": 12, "dose": null}
    ],
    "control": "placebo",
    "masking": "double",
    "strategy": "individual_child",
    "comparisons": [
      {"treated_arm": "SMC plus azithromycin", "control_arm": "SMC plus placebo", "strategy": "individual_child"}
    ],
    "mortality_outcome": {"ages": "3-59 months", "ascertainment": "other", "primary": false, "description": "Deaths recorded through active and passive surveillance at hospitals and health facilities, with verbal autopsy for deaths outside facilities, as part of the primary composite of 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). Death alone is not named as an outcome in this text."},
    "co_interventions": ["seasonal malaria chemoprevention (SP plus amodiaquine), four monthly 3-day courses each season (both arms)"],
    "registration": ["NCT02211729"],
    "notes": "SMC+AZ trial (Hounde, Burkina Faso; Bougouni, Mali): mortality appears only within the composite primary end point, and the azithromycin dose and its days within each 3-day cycle are not stated. Rounds are 4 cycles in each of 3 seasons; children were enrolled each season and stopped at 5 years (planned 19,200; 30,977 contributed), with per-arm household counts not given."
  },
  {
    "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": "infants at the pentavalent-1 (DTP-1) visit at about 6 weeks (enrolled up to 10 weeks), then at 9 and 15 months", "placebo_ages": null, "frequency": "three doses at EPI visits (6 weeks, 9 months, 15 months)", "rounds": 3, "dose": "20 mg/kg"},
      {"label": "Group 2 (placebo)", "azithromycin_ages": null, "placebo_ages": "infants at the pentavalent-1 (DTP-1) visit at about 6 weeks (enrolled up to 10 weeks), then at 9 and 15 months", "frequency": "three doses at EPI visits (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": "enrolment (6-10 weeks) to 18 months of age", "ascertainment": "other", "primary": true, "description": "All-cause mortality rate up to 18 months of age (Cox regression), deaths captured by a demographic surveillance system in each health facility's catchment area with passive and active case detection, and verbal autopsy for deaths in the community."},
    "co_interventions": ["perennial malaria chemoprevention (IPTi) with sulfadoxine-pyrimethamine at 10 and 14 weeks and 6, 9, 12 and 15 months (both arms)"],
    "registration": ["NCT04235816"],
    "notes": "ICARIA, registration and protocol only: doses go with routine EPI contacts, the last at 15 months, beyond infancy, and both arms get IPTi/PMC-SP though the registration calls the design factorial. Planned 20,560 infants (10,280 per arm); actual counts not given."
  },
  {
    "trial": "T14",
    "eligible": true,
    "exclusion_reason": null,
    "unit": "individual",
    "units": null,
    "countries": ["Mali"],
    "period": {"start": "2020-09", "end": "2025-03"},
    "arms": [
      {"label": "Infant azithromycin", "azithromycin_ages": "infants at the Penta-1 and Penta-3 (DTP-1 and DTP-3) visits, about 6 and 14 weeks", "placebo_ages": null, "frequency": "two doses at EPI visits", "rounds": 2, "dose": "20 mg/kg (up to 1 g)"},
      {"label": "Infant placebo", "azithromycin_ages": null, "placebo_ages": "infants at the Penta-1 and Penta-3 (DTP-1 and DTP-3) visits, about 6 and 14 weeks", "frequency": "two doses at EPI visits", "rounds": 2, "dose": null}
    ],
    "control": "placebo",
    "masking": "double",
    "strategy": "individual_infant",
    "comparisons": [
      {"treated_arm": "Infant azithromycin", "control_arm": "Infant placebo", "strategy": "individual_infant"}
    ],
    "mortality_outcome": {"ages": "first dose (about 6 weeks) to 6-12 months of age", "ascertainment": "follow_up_visit", "primary": true, "description": "Co-primary aim 1B: infant mortality from the first infant dose through 6-12 months of age, vital status at the 6- and 12-month study visits (at least three contact attempts). Co-primary aim 1A, for the maternal intervention, is stillbirth plus infant death."},
    "co_interventions": ["maternal azithromycin 2 g or placebo at antenatal visits and delivery (factorial, mother-infant cohort)", "seasonal malaria chemoprevention (SP plus amodiaquine), monthly July-October, children 3-59 months (standard of care)", "intermittent preventive treatment in pregnancy with sulfadoxine-pyrimethamine (standard of care)"],
    "registration": ["NCT03909737"],
    "notes": "SANTE, registration and protocol only: a 2x2 factorial (maternal by infant azithromycin) in a rural mother-infant cohort plus a 1:1 infant-only cohort, coded at the infant factor; the registration lists six arms and also an urban Bamako cohort randomized mother and infant in tandem, absent from the protocol. Planned 49,600 pairs and 12,000 infants; actual counts not given."
  },
  {
    "trial": "T15",
    "eligible": false,
    "exclusion_reason": "Azithromycin was given only together with nitazoxanide (the antimicrobial factor of a 2x2 factorial with nicotinamide), so no comparison isolates azithromycin; and it is a growth trial in an enrolled cohort of 1,188 neonates, not azithromycin to every child of a community or every infant a programme or visit reaches.",
    "unit": "individual",
    "units": null,
    "countries": ["Tanzania"],
    "period": {"start": "2017-09", "end": "2020-02"},
    "arms": [
      {"label": "Antimicrobials (azithromycin + nitazoxanide)", "azithromycin_ages": "infants enrolled at 0-14 days (ages at dosing not stated)", "placebo_ages": null, "frequency": "scheduled (schedule not stated)", "rounds": null, "dose": null},
      {"label": "Antimicrobial placebo", "azithromycin_ages": null, "placebo_ages": "infants enrolled at 0-14 days (ages at dosing not stated)", "frequency": "scheduled (schedule not stated)", "rounds": null, "dose": null}
    ],
    "control": "placebo",
    "masking": "double",
    "strategy": "other",
    "comparisons": [
      {"treated_arm": "Antimicrobials (azithromycin + nitazoxanide)", "control_arm": "Antimicrobial placebo", "strategy": "other"}
    ],
    "mortality_outcome": {"ages": "0-18 months", "ascertainment": null, "primary": false, "description": "All-cause mortality from 0 to 18 months, a secondary outcome; the primary outcome is length-for-age z-score at 18 months. How deaths are ascertained is not described."},
    "co_interventions": ["daily nicotinamide (vitamin B3) or placebo (factorial)"],
    "registration": ["NCT03268902"],
    "notes": "ELICIT: the four registered arms are coded at the antimicrobial factor (azithromycin given only with nitazoxanide), and dose, schedule and ages at dosing are not given (the abstract stops before its methods). Enrolment requires a mother of at least 18, a singleton of at least 1500 g, and breastfeeding."
  },
  {
    "trial": "T16",
    "eligible": false,
    "exclusion_reason": "Staff visited households with children under 5 in Nouna town and interested caregivers brought them to the district hospital, so azithromycin went to the 450-500 children enrolled in a growth and microbiome trial, not to every child of a community 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 and 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 treatment", "ascertainment": "follow_up_visit", "primary": false, "description": "Death within 180 days of treatment, vital status at each follow-up visit (14 days and 6 months), registered as a secondary outcome; the report's Methods name only anthropometric outcomes, and the registration's primary outcomes are gut microbial diversity and macrolide resistance."},
    "co_interventions": [],
    "registration": ["NCT03676751"],
    "notes": "GAMIN, run in Nouna town alongside the MORDOR II Burkina Faso trial: per-arm counts are not given (225 per arm planned; registration enrollment 500), and mortality appears only in the registration. Strategy coded other since the single dose went to enrolled children rather than through a programme or visit; the period is the report's (registration 2019-10 to 2020-07)."
  }
]