Massive trial tests azithromycin to prevent stillbirths and infant deaths in west africa
NCT ID NCT03909737
First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 1 time
Summary
This study tests whether giving the antibiotic azithromycin to pregnant women and their babies during routine care can prevent stillbirths and infant deaths in Mali, a country with very high infant mortality. Over 99,000 participants are involved in this large, placebo-controlled trial. The goal is to find a simple, low-cost way to save lives.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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99,700 people
The number who actually took part.
- Started
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Sep 2020
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Pregnant women: 1. Participant is attending an ANC visit between 13 and 37 weeks gestation, with gestational age estimated using fundal height measurements and/or maternal report of quickening, at a participating health facility. 2. Participant is able to understand and comply with planned study procedures. 3. Participant has provided informed consent prior to initiation of any study procedures. 4. Participant intends to reside in the study area until her newborn infant is at least 12 months old. Infants: Enrollment of pregnant women and their unborn infants will happen simultaneously. Infants attending routine immunization visits at eligible health facilities whose mothers were not enrolled in the study will be eligible for enrollment in the supplemental infant cohort within the rural study cohort with the following inclusion criteria: 1. Infant is \<12 mo attending a DTP-1 routine vaccination visit at a participating health facility. 2. Parent or guardian is able to understand and comply with planned study procedures. 3. Parent or guardian has provided informed consent prior to initiation of any study procedures. 4. Parent or guardian intends to reside in the study area until participant is at least 12 months old. Exclusion Criteria: 1. Allergy to macrolides or azalides. 2. Any condition that, in the opinion of the investigator, might compromise the well-being of the participant or compliance with study procedures. 3. Medical treatment that requires administration of azithromycin (this can be a temporary exclusion if the drug is later discontinued).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Centre pour le Developpement des Vaccins - Mali
Bamako, Mali