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Oral Azithromycin to Prevent Stillbirths and Infant Mortality in Mali
Sponsor: University of Maryland, Baltimore
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
Conditions
Interventions
Azithromycin to pregnant women
Azithromycin to pregnant women at antenatal care visits and during delivery
Azithromycin to infants
Azithromycin to infants at 6 and 14 week EPI visits
Placebo to pregnant women
Placebo to pregnant women at antenatal care visits and during delivery
Placebo to infants
Placebo to infants at 6 and 14 week EPI visits
No intervention to pregnant women
No intervention to pregnant women
Locations (1)
Centre pour le Developpement des Vaccins - Mali
Bamako, Mali