NCT03909737

Oral Azithromycin to Prevent Stillbirths and Infant Mortality in Mali

Sauver Avec l'Azithromycine en Traitant Les Femmes Enceintes et Les Enfants (SANTE)

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 99,700 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Detailed description

This trial will assess the efficacy of oral azithromycin given during routine health care visits 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. Using an individually randomized placebo-controlled double-masked trial design, pregnant women will receive a single dose of oral azithromycin or placebo at their second and/or third trimester antenatal care visits and during labor, and to infants at their DPT-1 and DPT-3 vaccination visits, which occur at approximately 6 and 14 weeks of age, respectively. The two co-primary outcomes are (1A) a composite outcome of stillbirths and mortality through 6-12 months of age and (1B) mortality between 6 weeks and 6-12 months of age. The study sample size is powered to detect a 20% relative reduction in both of the two co-primary outcomes. The study is designed to inform policymakers regarding the effectiveness of azithromycin for the prevention of stillbirth and infant mortality in both urban and rural parts of the country when administered during routine antenatal and intrapartum care and infant immunization visits. To achieve this aim, three cohorts will be enrolled: a mother-infant cohort in a rural part of the country with infant mortality rates that are higher than the national average, a supplemental infant-only cohort enrolled form the same rural communities, and third urban mother-infant cohort residing in Bamako, Mali's capital. Sub studies designed to elucidate the protective mechanisms of azithromycin treatment will be embedded within the larger study and will be added in the future.

Conditions

• Stillbirths and Infant Mortality

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-09-24
• Primary completion: 2025-03-01
• Completion: 2026-03-31
• First posted: 2019-04-10
• Last updated: 2026-02-02

Locations

1 site across 1 country: Mali

Regulatory

• FDA-regulated drug study