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Oral Azithromycin to Prevent Stillbirths and Infant Mortality in Mali

NCT03909737 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 99700

Last updated 2026-02-02

No results posted yet for this study

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.

Conditions

  • Stillbirths and Infant Mortality

Interventions

DRUG

Azithromycin to pregnant women

Azithromycin to pregnant women at antenatal care visits and during delivery

DRUG

Azithromycin to infants

Azithromycin to infants at 6 and 14 week EPI visits

OTHER

Placebo to pregnant women

Placebo to pregnant women at antenatal care visits and during delivery

OTHER

Placebo to infants

Placebo to infants at 6 and 14 week EPI visits

OTHER

No intervention to pregnant women

No intervention to pregnant women

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • Karen L Kotloff, MD · University of Maryland, Baltimore

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-24
Primary Completion
2025-03-01
Completion
2026-03-31
FDA Drug
Yes

Countries

  • Mali

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03909737 on ClinicalTrials.gov