overview
The SANTÉ trial in Mali tested whether giving azithromycin to pregnant women during antenatal care and at delivery, as well as to infants alongside routine vaccinations, could reduce stillbirths and infant mortality.
It enrolled over 50,000 women and 12,000 infants in a large, randomized, placebo-controlled study across southern Mali.
The trial also examined safety, antimicrobial resistance, and the feasibility of integrating azithromycin dosing into routine health services.
SANTÉ stands for “Sauver avec l’Azithromycine en Traitant les Femmes Enceintes et les Enfants” – “Saving [lives] with azithromycin by treating pregnant women and infants”.
Details
Aim
The SANTÉ trial aimed to determine whether giving oral azithromycin to both pregnant women and young infants could reduce stillbirths and infant mortality in Mali. Pregnant women received the antibiotic twice during antenatal care visits in the second and third trimesters, as well as once during labor or shortly thereafter. Infants received azithromycin at the same time as their routine pentavalent vaccinations at approximately six and fourteen weeks of age. The trial tested whether integrating azithromycin dosing into existing maternal and child health services could improve survival outcomes.
Design & Scope
The trial was designed as an individually randomized, placebo-controlled, double-blinded study. Pregnant women were randomly assigned to receive either azithromycin or placebo during antenatal care and again at delivery, while infants were similarly randomized to receive azithromycin or placebo at vaccination visits. The study enrolled more than 50,000 pregnant women across three districts in southern Mali and included about 12,000. In addition, sub-studies conducted in 21 health areas investigated antimicrobial resistance and implementation processes.
Primary and Secondary Objectives
The first primary objective was to measure whether maternal azithromycin, given twice during pregnancy and again during labor, reduced the combined rate of stillbirths and infant deaths through at least six months of age. The second primary objective was to determine whether infant azithromycin, given at the time of the first and third pentavalent vaccine doses, reduced infant mortality from the time of the first dose through at least six months of age.
Secondary objectives focused on safety, monitoring antimicrobial resistance, and evaluating feasibility and coverage within the routine health system.
Timeline
Follow-up of the primary outcome data was completed in April 2024. Analyses of primary efficacy and safety were scheduled for release in 2025. Antimicrobial resistance testing remains ongoing, with results expected soon after the main readout. Participants in the sub-studies were followed until February 2025.
Implementation & Oversight
The trial was implemented by the Center for Vaccine Development–Mali in partnership with the University of Maryland, Baltimore. It was funded by the Bill & Melinda Gates Foundation. Oversight included safety monitoring, antimicrobial resistance surveillance, and assessment of how effectively the intervention could be delivered through routine antenatal and immunization services.
