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ACTIVE NOT RECRUITING
NCT03909737
PHASE4

Oral Azithromycin to Prevent Stillbirths and Infant Mortality in Mali

Sponsor: University of Maryland, Baltimore

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

99700

Start Date

2020-09-24

Completion Date

2026-03-31

Last Updated

2026-02-02

Healthy Volunteers

Yes

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

Locations (1)

Centre pour le Developpement des Vaccins - Mali

Bamako, Mali