Abstract
BackgroundBiannual, 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/designThe 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.DiscussionThis 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 registrationClinicalTrials.gov, ID: NCT03676764. Registered on 19 September 2018; prospectively registered pre results.
Highlights
Biannual, mass azithromycin distribution has previously been shown to reduce all-cause child mortality in sub-Saharan Africa
Despite a secular trend of decreasing under-5 mortality rate (U5MR) across sub-Saharan Africa, childhood mortality remains persistently high in some regions [1]
Individuals born into the communities who are between 5 and 12 weeks of age are randomized in a 1:1 fashion to a single dose of directly observed, orally administered azithromycin or placebo during a healthy child visit at a participating Centre de Santé et de Promotion Sociale (CSPS)
Summary
Mass azithromycin distribution has previously been shown to reduce all-cause child mortality in sub-Saharan Africa. 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. Despite a secular trend of decreasing under-5 mortality rate (U5MR) across sub-Saharan Africa, childhood mortality remains persistently high in some regions [1]. The MORDOR study recently showed that biannual, mass azithromycin distribution reduces all-cause child mortality by 14% compared to placebo in districts in Niger, Tanzania, and Malawi [2]. Mass drug administration with azithromycin has been used by trachoma control programs for decades [3] and is highly effective at clearing the ocular strains of Chlamydia trachomatis that cause trachoma [4, 5].
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