A double-masked placebo-controlled trial of azithromycin to prevent child mortality in Burkina Faso, West Africa: Community Health with Azithromycin Trial (CHAT) study protocol

Ali Sié, Mamadou Ouattara, Mamadou Bountogo, Cheik Bagagnan, Boubacar Coulibaly, Valentin Boudo, Elodie Lebas, Jessica M Brogdon, Ying Lin, Till Bärnighausen, Travis C Porco, Thuy Doan, Thomas M Lietman, Catherine E Oldenburg, Étude CHAT Study Group, Ali Sié, Mamadou Ouattara, Mamadou Bountogo, Cheik Bagagnan, Boubacar Coulibaly, Valentin Boudo, Elodie Lebas, Jessica M Brogdon, Ying Lin, Till Bärnighausen, Travis C Porco, Thuy Doan, Thomas M Lietman, Catherine E Oldenburg, Étude CHAT Study Group

Abstract

Background: Biannual, mass azithromycin distribution has previously been shown to reduce all-cause child mortality in sub-Saharan Africa. Subgroup analysis suggested that the strongest effects were in the youngest children, leading to the hypothesis that targeting younger age groups might be an effective strategy to prevent mortality. We present the methods of two randomized controlled trials designed to evaluate mass and targeted azithromycin distribution for the prevention of child mortality in Burkina Faso, West Africa.

Methods/design: The Child Health with Azithromycin Treatment (CHAT) study consists of two nested, randomized controlled trials. In the first, communities are randomized in a 1:1 fashion to biannual, mass azithromycin distribution or placebo. The primary outcome is under-5 all-cause mortality measured at the community level. In the second, children attending primary healthcare facilities during the first 5-12 weeks of life for a healthy child visit (e.g., for vaccination) are randomized in a 1:1 fashion to a single orally administered dose of azithromycin or placebo. The primary outcome is all-cause mortality measured at 6 months of age. The trial commenced enrollment in August 2019.

Discussion: This study is expected to provide evidence on two health systems delivery approaches (mass and targeted treatment) for azithromycin to prevent all-cause child mortality. The results will inform global and national policies related to azithromycin for the prevention of child mortality.

Trial registration: ClinicalTrials.gov, ID: NCT03676764. Registered on 19 September 2018; prospectively registered pre results.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Study flow diagram for the Child Health with Azithromycin Treatment (CHAT) study in Nouna District, Burkina Faso, West Africa. This study is a hierarchical factorial study in which communities are randomized to biannual, mass, single-dose azithromycin or placebo distribution to all children aged 1–59 months and infants aged 5–12 weeks are individually randomized to a single dose of azithromycin or placebo. Abbreviations: MDA mass drug administration, CSPS Centre de Santé et de Promotion Sociale (primary healthcare facility)
Fig. 2
Fig. 2
Study area in Nouna District, Burkina Faso, West Africa. The shaded area indicates the Nouna Health and Demographic Surveillance site area of Nouna District. Primary health facilities are indicated with red crosses. Abbreviations: HDSS Health and Demographic Surveillance Site, NIG-GIS geographic information system
Fig. 3
Fig. 3
Study assessments for community randomization (a) and individual randomization (b)

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