CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 77,664 enrolled
Drug / intervention
Azithromycin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03676764
NCT03676764Phase 4Completed

Community Health Azithromycin Trial in Burkina Faso

University of California, San Francisco·interventional·Posted Sep 19, 2018·Updated Feb 24, 2025

In Brief

A Phase 4 clinical trial evaluating Azithromycin and Placebos for Childhood Mortality. Completed, enrolled 77,664 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBurkina Faso

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedSep 19, 2018
Enrollment StartAug 1, 2019
Primary CompletionDec 1, 2023
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 7.8 years ago

Interventions

Azithromycindrug

biannual azithromycin in eligible communities to children 1 to 59 months old Targeted azithromycin to children aged 5 to 8 weeks old at the vaccine visit

Placebosdrug

biannual placebo in eligible communities to children 1 to 59 months old Targeted placebo to children aged 5 to 8 weeks old at the vaccine visit