NCT03909737|Active Not RecruitingPhase 4DMCFDA Drug
Oral Azithromycin to Prevent Stillbirths and Infant Mortality in Mali
SANTE
Sauver Avec l'Azithromycine en Traitant Les Femmes Enceintes et Les Enfants (SANTE)
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Sponsor study identifier
interventional
99,700
1 country
1
Study Start
September 24, 2020
Actual (reported)Primary Completion
March 1, 2025
Actual (reported)Study Completion
March 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 26, 2019
Actual (reported)April 10, 2019
Actual (reported)September 24, 2020
Actual (reported)March 1, 2025
Actual (reported)March 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Rate of stillbirths and infant mortality through 6-12 months of age
Delivery outcomes assessed at intrapartum study visit and infant vital status assessed at 6 and 12 month study visits.
6 to 12 months
Rate of infant mortality between 6 weeks and 12 months of age
Infant vital status will be assessed at 6 and 12 month study visits.
6 weeks to 12 months
Gestational age at birth
3-6 months
Birth weight
3-6 months
The incremental cost-effectiveness ratio of adding azithromycin to standard of care in Mali
6 to 18 months
2 gram oral dose of Azithromycin to pregnant women at their 2nd and 3rd trimester antenatal care visits and during delivery, plus 20 mg/kg to 1 gram oral dose of azithromycin to infants at 6 and 14 week Expanded Programme on Immunization (EPI) visits
2 gram oral dose of Azithromycin to pregnant women at their 2nd and 3rd trimester antenatal care visits and during delivery, plus oral placebo to infants at 6 and 14 week EPI visits
Azithromycin to pregnant women at antenatal care visits and during delivery
Azithromycin to infants at 6 and 14 week EPI visits
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Control intervention
Placebo to pregnant women
The registry describes a control or simulated intervention. Active treatment exposure is not inferred.
View registry recordControl intervention
Placebo to infants
The registry describes a control or simulated intervention. Active treatment exposure is not inferred.
View registry recordCentre pour le Developpement des Vaccins - Mali
Bamako, Mali
Driscoll AJ, Haidara FC, Tapia MD, Deichsel EL, Samake OS, Bocoum T, Bailey JA, Fitzpatrick MC, Goldenberg RL, Kodio M, Moulton LH, Nasrin D, Onwuchekwa U, Shaffer AM, Sow SO, Kotloff KL. Antenatal, intrapartum and infant azithromycin to prevent stillbirths and infant deaths: study protocol for SANTE, a 2x2 factorial randomised controlled trial in Mali. BMJ Open. 2023 Aug 30;13(8):e067581. doi: 10.1136/bmjopen-2022-067581.
Karen L Kotloff, MD
University of Maryland, Baltimore
99,700 participants (actual enrollment reported by the registry).
Oral placebo to pregnant women at their 2nd and 3rd trimester antenatal care visits and during delivery, plus 20 mg/kg to 1 gram oral dose of azithromycin to infants at 6 and 14 week EPI visits
Placebo to pregnant women at their 2nd and 3rd trimester antenatal care visits and during delivery, plus oral placebo to infants at 6 and 14 week EPI visits
No intervention to pregnant women and 20 mg/kg to 1 gram oral dose of azithromycin to infants at 6 and 14 week EPI visits
No intervention to pregnant women and placebo to infants at 6 and 14 week EPI visits
Placebo to pregnant women at antenatal care visits and during delivery
Placebo to infants at 6 and 14 week EPI visits
No intervention to pregnant women
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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First Submitted
February 26, 2019
First Posted
April 10, 2019
Study Start
September 24, 2020
Actual (reported)Primary Completion
March 1, 2025
Actual (reported)Study Completion
March 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 7, 2026
Record last verified: 2025-09
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Source: ClinicalTrials.gov.
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