NCT04716712

Infant Mortality Reduction by the Mass Administration of Azithromycin

Mortalite Infantile Reduite Par l'Administration de Masse de l'Azitromycine

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 694,400 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 1 Month – 11 Months
• Healthy volunteers: Accepted

Summary

This trial will investigate the supplementation of azithromycin distribution to the "Child Health Days" platform in Burkina Faso for child mortality reduction. This distribution will pair door-to-door administration of vitamin A and azithromycin or placebo with acute malnutrition screening among children 1-11 months old.

Detailed description

The MORDOR clinical trial funded by the Bill \& Melinda Gates Foundation in Malawi, Tanzania, and Niger demonstrated that biannual oral azithromycin distributions to children aged 1-59 months significantly reduced child mortality. The investigators hypothesize that biannual administration of azithromycin to children aged 1-11 months will reduce mortality in this age group. The aim of the project is to demonstrate that this intervention can be scaled up and produce the same benefits on mortality as those documented in smaller, more controlled studies. Since 1986, to reduce child mortality, Burkina Faso has been administering high-dose vitamin A supplementation to children aged 6-59 months on a biannual basis through the "Child Health Days" platform. The "Child Health days" are a door-to-door distribution of vitamin A coupled with screening for acute malnutrition in children aged 6-59 months and deworming of children aged 12-59 months. This approach has been successful but expensive. A new strategy implemented since September 2017 relies on community-based health workers (CBHWs) to distribute Vitamin A in rural areas, and on community-based distributors (CDs) in urban areas. Based on expert opinion and the preliminary findings of formative research conducted by the Ministry of Health and Helen Keller International, it was agreed that the Child Health Days platform was the most appropriate platform to implement the biannual administration of azithromycin to children aged 1 to 11 months. In this trial, mortality will be measured via complete birth history which will be collected in a subset of villages in the study area before the first treatment distribution. The study team will also conduct a baseline census of the study areas for treatment coverage estimations. Sixty villages (30 azithromycin, 30 placebo) will contribute to the macrolide resistance outcomes, where the study team will collect rectal and nasal swabs from children 1-59 months.

Conditions

• Child Mortality

Interventions

Type	Name	Description
DRUG	Azithromycin	Azithromycin is a macrolide-type antibiotic that is used to treat various types of infections. Previous studies in Niger have demonstrated a nearly 18% reduction in all-cause child mortality following biannual mass administration to children 1-59 months.
DRUG	Placebo	Matching identical placebo in packaging, appearance, and taste.

Timeline

• Start date: 2021-10-04
• Primary completion: 2025-01-30
• Completion: 2026-01-30
• First posted: 2021-01-20
• Last updated: 2025-03-13

Locations

3 sites across 2 countries: United States, Burkina Faso

Regulatory

• FDA-regulated drug study