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

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.

Distance to primary care facilities and healthcare utilization for preschool children in rural northwestern Burkina Faso: results from a surveillance cohort

“…This study took place in Nouna district in northwestern Burkina Faso [ 9 ]. The area is primarily rural and agrarian [ 10 ].…”

“…The area is primarily rural and agrarian [ 10 ]. All communities in Nouna District and all primary healthcare facilities were eligible for inclusion in the study [ 9 ]. Data on clinic visits were collected from March 1 through May 31, 2020, which corresponds to the dry season and low malaria transmission season in the study area, and the period in between the annual harvest and the annual planting season.…”

“…Data on clinic visits were collected from March 1 through May 31, 2020, which corresponds to the dry season and low malaria transmission season in the study area, and the period in between the annual harvest and the annual planting season. Data were collected during the dry season due to logistical reasons from the parent study so that timing was shortly after the baseline census (described below) [ 9 ]. Primary healthcare in rural Burkina Faso is delivered via Centres de Santé et de Promotion Sociale (CSPS), which are typically nurse-led rural healthcare units that deliver first-line preventive and therapeutic care.…”

“…The census took place from August 2019 through February 2020. Complete methods for the census have been previously reported [ 9 ]. The head of each household in each study community was asked if there were any children under 5 years of age living in the household, and those in households with children were asked to list each child.…”

Rapid Reduction of Campylobacter Species in the Gut Microbiome of Preschool Children after Oral Azithromycin: A Randomized Controlled Trial

“…Alternative strategies could include distribution from a fixed point, such as integration with childhood vaccination visits. 9 Individual distribution may affect transmission or burden of pathogens differently than community distribution. Here, we evaluated the short-term effect of a course of azithromycin compared with placebo on the detection of Campylobacter species in preschool children in rural Burkina Faso individually randomized to azithromycin or placebo.…”