Community Health Azithromycin Trial in Burkina Faso
Status:
Recruiting
Trial end date:
2024-12-01
Target enrollment:
Participant gender:
Summary
An estimated 7.7 million pre-school aged children die each year, the majority from infectious
diseases. Mass azithromycin distributions for trachoma may have the unintended benefit of
reducing childhood mortality. We recently demonstrated the biannual mass azithromycin
distribution significantly reduces all-cause child mortality in a cluster randomized trial
(MORDOR I) conducted in three diverse regions of Sub-Saharan Africa.
Our long-term goal is to more precisely define the role of mass azithromycin treatments as an
intervention for reducing childhood morbidity and mortality. We propose a cluster randomized
trial designed to repeat the original study to confirm the original results in a different
geographic study with similarly high child mortality, and to better understand the mechanism
behind any effect of azithromycin on child mortality. We hypothesize that biannual mass
azithromycin distribution will reduce child mortality compared to placebo, and that this
effect will be primarily driven by a reduction in infectious burden.
Objectives:
1. Determine the efficacy of biannual mass azithromycin distribution versus placebo in
children aged 1-59 months for reduction in all-cause mortality.
2. Determine the efficacy of targeted azithromycin distribution to infants during an early
infant healthcare visit (approximately 5th through 12th week of life) on infant
mortality.
3. Determine the mechanism behind the effect of biannual mass azithromycin distribution for
reduction in child mortality.
The study will be conducted in the Nouna District in northwestern Burkina Faso.
Phase:
Phase 4
Details
Lead Sponsor:
University of California, San Francisco
Collaborators:
Bill and Melinda Gates Foundation Centre de Recherche en Sante de Nouna, Burkina Faso