Oral Azithromycin to Prevent Stillbirths and Infant Mortality in Mali

Phase 4 Active not recruiting 99700 enrolled University of Maryland, Baltimore Bill and Melinda Gates Foundation · collab

RandomizedFactorialQuadruple-blindPrevention

Summary

The double blind randomized controlled trial will assess the efficacy of oral azithromycin administered to pregnant women and/or infants during routine care in preventing stillbirths and mortality through 6-12 months of age in Mali, West Africa, where rates of infant and under five mortality are among the highest in the world.

Timeline

Start: 2020-09-24
Primary completion: 2025-03-01
Completion: 2026-03-31

Publications

Driscoll AJ, Haidara FC, Tapia MD, Deichsel EL, Samake OS, Bocoum T, Bailey JA, Fitzpatrick MC, Goldenberg RL, Kodio M, Moulton LH, Nasrin D, Onwuchekwa U, Shaffer AM, Sow SO, Kotloff KL. Antenatal, intrapartum and infant azithromycin to prevent stillbirths and infant deaths: study protocol for SANTE, a 2x2 factorial randomised controlled trial in Mali. BMJ Open. 2023 Aug 30;13(8):e067581. doi: 10.1136/bmjopen-2022-067581.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Azithromycin	Small molecule	20 mg/kg	Oral
Subject	Azithromycin	Small molecule	2 g	Oral

Indications

No indication recorded.