Integration of azithromycin mass administration to 1–11-month-old children into an existing health platform to reduce child mortality

A cluster-randomised trial in Burkina Faso

Bibliographic Data

ID21879366
AuthorsFanny Yago-Wienne (Helen Keller International), Djeinam Touré (0000-0002-8392-1168, Helen Keller International), Georges Dimithé (Helen Keller International), Regina Khassanova (Helen Keller International), Souleymane Sidibé (Helen Keller International), Pouorinibé Noel Some (Helen Keller International), Issouf Bamba (Helen Keller International), Valérie Zombré (Ministère de la Santé), Ali Sié (0000-0002-3959-2520, Centre de Recherche en Sante de Nouna, Nouna, Burkina Faso), A B Sie (Centre de Recherche en Santé de Nouna), Mamadou Bountogo (0000-0001-5010-1617, Centre de Recherche en Santé de Nouna), Boubacar Coulibaly (0000-0001-9868-6503, Centre de Recherche en Santé de Nouna), Mamadou Ouattara (0000-0002-4650-9676, Centre de Recherche en Santé de Nouna), Brittany Peterson (0009-0008-8815-1642, University of California, San Francisco), Benjamin Arnold (0000-0001-7591-2539, University of California, San Francisco), Thomas M Lietman (0000-0001-8216-0240, University of California, San Francisco), Élodie Lebas (0000-0003-1617-143X, University of California, San Francisco), Kieran S O’Brien (0000-0002-1962-5321, University of California, San Francisco)
Year2026
Volume11
Issue1
Pagese021336
Publication date2026-01-01
Peer ReviewedYes
Open AccessYes
TypeARTICLE
VenueBMJ Global Health (JOURNAL)
Journal identifiersISSN: 2059-7908 • E-ISSN: 2059-7908
PublisherBMJ (PUBLISHER • GB)
DOI10.1136/bmjgh-2025-021336
PMID41506755
OpenAlexW7119474558
LanguageEN
Citations received2
References cited22

BACKGROUND: Azithromycin mass drug administration (MDA) to ages 1-59 months can reduce childhood mortality; however, more evidence is needed to support targeting a narrower age range of 1-11 months. This trial assesses the efficacy of azithromycin MDA to 1-11-month-old children in reducing mortality in a real-world setting with integration of vitamin A delivery within the established Child Health Days platform in Burkina Faso. METHODS: Mortalite Infantile Reduite par l'Administration de Masse de l'Azithromycine is a double-masked, cluster-randomised, placebo-controlled trial in Child Health Days communities in Burkina Faso. Primary healthcare centre catchment areas (Centres de Santé et de Promotion Sociale (CSPS)) were randomised 2:1 to deliver biannual azithromycin or placebo for 1-11-month-old children. Birth history data at the study endpoint were used to calculate mortality rates and compare between groups. FINDINGS: From September 2021 to January 2024, 201 709 children in 303 CSPS received azithromycin and 100 959 children in 158 CSPS received placebo, with an overall treatment coverage of 85%. Mortality rates were 2.6 (95% CI 2.1 to 3.1) deaths per 1000 person-years in the azithromycin arm and 2.5 (95% CI 1.8 to 3.2) per 1000 person-years in the placebo arm. There was no significant difference in the mortality rates by arm (incidence rate ratio: 1.04; 95% CI 0.75 to 1.46; p value 0.80). There were 16 non-serious adverse events and no serious adverse events recorded during the trial. INTERPRETATION: This trial demonstrates that azithromycin MDA for child survival can be scaled up and integrated into existing child health programmes but was unable to demonstrate an effect of azithromycin distribution on infant mortality. These findings indicate future policy decisions should consider treatment delivery to the larger age group of children up to 5 years old. FUNDING: The trial was funded by the Bill and Melinda Gates Foundation (INV-005395). TRIAL REGISTRATION NUMBER: NCT04716712

Azithromycin · Child health · Health services research · Mass drug administration · Public health · Child Nutrition and Water Access · Global Maternal and Child Health · Pharmaceutical studies and practices