{
  "abstract": "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.",
  "authors": [
    {
      "affiliations": [
        "Helen Keller International, Ouagadougou, Burkina Faso"
      ],
      "name": "Fanny Yago-Wienne"
    },
    {
      "affiliations": [
        "Hellen Kelle Intl, Dakar, Senegal"
      ],
      "name": "Djeinam Toure"
    },
    {
      "affiliations": [
        "Helen Keller International, Ouagadougou, Burkina Faso"
      ],
      "name": "Georges Dimithé"
    },
    {
      "affiliations": [
        "Helen Keller International, Ouagadougou, Burkina Faso"
      ],
      "name": "Regina Khassanova"
    },
    {
      "affiliations": [
        "Helen Keller International, Ouagadougou, Burkina Faso"
      ],
      "name": "Souleymane Sidibé"
    },
    {
      "affiliations": [
        "Helen Keller International, Ouagadougou, Burkina Faso"
      ],
      "name": "Pouorinibé Noel Some"
    },
    {
      "affiliations": [
        "Helen Keller International, Ouagadougou, Burkina Faso"
      ],
      "name": "Issouf Bamba"
    },
    {
      "affiliations": [
        "Ministère de la santé, Ouagadougou, Burkina Faso, Ouagadougou, Burkina Faso"
      ],
      "name": "Valérie Zombré"
    },
    {
      "affiliations": [
        "Centre de Recherche en Sante de Nouna, Nouna, Burkina Faso"
      ],
      "name": "Ali Sie"
    },
    {
      "affiliations": [
        "Centre de Recherche en Sante de Nouna, Nouna, Burkina Faso"
      ],
      "name": "Mamadou Bountogo"
    },
    {
      "affiliations": [
        "Centre de Recherche en Sante de Nouna, Nouna, Burkina Faso"
      ],
      "name": "Boubacar Coulibaly"
    },
    {
      "affiliations": [
        "Centre de Recherche en Sante de Nouna, Nouna, Burkina Faso"
      ],
      "name": "Mamadou Ouattara"
    },
    {
      "affiliations": [
        "Francis I. Proctor Foundation, University of California San Francisco, San Francisco, California, USA",
        "Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, California, USA"
      ],
      "name": "Brittany Peterson"
    },
    {
      "affiliations": [
        "Francis I. Proctor Foundation, University of California San Francisco, San Francisco, California, USA",
        "Department of Opthalmology, University of California San Francisco, San Francisco, California, USA",
        "Institute for Global Health Sciences, University of California, San Francisco, San Francisco, CA, USA"
      ],
      "name": "Benjamin Arnold"
    },
    {
      "affiliations": [
        "Francis I. Proctor Foundation, University of California San Francisco, San Francisco, California, USA",
        "Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, California, USA",
        "Department of Opthalmology, University of California San Francisco, San Francisco, California, USA",
        "Institute for Global Health Sciences, University of California, San Francisco, San Francisco, CA, USA"
      ],
      "name": "Thomas M Lietman"
    },
    {
      "affiliations": [
        "Francis I. Proctor Foundation, University of California San Francisco, San Francisco, California, USA"
      ],
      "name": "Elodie Lebas"
    },
    {
      "affiliations": [
        "Francis I. Proctor Foundation, University of California San Francisco, San Francisco, California, USA",
        "Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, California, USA",
        "Department of Opthalmology, University of California San Francisco, San Francisco, California, USA",
        "Institute for Global Health Sciences, University of California, San Francisco, San Francisco, CA, USA"
      ],
      "name": "Kieran S O’Brien"
    }
  ],
  "title": "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",
  "uid": "0ce82d15-926d-55a7-b04f-0347240da503"
}