drugset / Trial / NCT04716712
Infant Mortality Reduction by the Mass Administration of Azithromycin
Phase 4
Active not recruiting
694400 enrolled
University of California, San Francisco
Bill and Melinda Gates Foundation · collabCentre de Recherche en Sante de Nouna, Burkina Faso · collabHelen Keller International · collab
RandomizedFactorialQuadruple-blindPrevention
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.
Timeline
- Start
- 2021-10-04
- Primary completion
- 2025-01-30
- Completion
- 2026-01-30
Publications
- Background Keenan JD, Bailey RL, West SK, Arzika AM, Hart J, Weaver J, Kalua K, Mrango Z, Ray KJ, Cook C, Lebas E, O'Brien KS, Emerson PM, Porco TC, Lietman TM; MORDOR Study Group. Azithromycin to Reduce Childhood Mortality in Sub-Saharan Africa. N Engl J Med. 2018 Apr 26;378(17):1583-1592. doi: 10.1056/NEJMoa1715474.
- Yago-Wienne F, Toure D, Dimithe G, Khassanova R, Sidibe S, Some PN, Bamba I, Zombre V, Sie A, Bountogo M, Coulibaly B, Ouattara M, Peterson B, Arnold B, Lietman TM, Lebas E, O'Brien KS. Integration of azithromycin mass administration to 1-11-month-old children into an existing health platform to reduce child mortality: a cluster-randomised trial in Burkina Faso. BMJ Glob Health. 2026 Jan 8;11(1):e021336. doi: 10.1136/bmjgh-2025-021336.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Azithromycin | Small molecule | — | Oral |
Indications
No indication recorded.