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Oral Azithromycin to Prevent Stillbirths and Infant Mortality in Mali

Study acronym: SANTE
StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study completion pushed from Mar 31, 2026 to Mar 31, 2027v14
  2. Primary completion date: Feb 1, 2025 to Mar 1, 2025
    • Study completion date: Dec 31, 2025 to Mar 31, 2026
    v13
  3. Primary completion date: Feb 1, 2024 to Feb 1, 2025v12
  4. Re-verified, no change to tracked fieldsv11
  5. Primary completion date: Aug 28, 2023 to Feb 1, 2024v10
Show 8 earlier versionsHide 8 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Oct 1, 2024 to Aug 28, 2023
    • Study completion date: Oct 1, 2024 to Dec 31, 2025
    • Site details revised
    v9
  2. Primary and study completion dates: Oct 1, 2023 to Oct 1, 2024v8
  3. Re-verified, no change to tracked fieldsv7
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 15, 2020 to Sep 24, 2020
    • Primary and study completion dates: Apr 15, 2023 to Oct 1, 2023
    • Site details revised
    v6
  5. Start date: Feb 15, 2020 to Apr 15, 2020
    • Primary and study completion dates: Feb 15, 2023 to Apr 15, 2023
    v5
  6. Primary completion date: Feb 1, 2022 to Feb 15, 2023
    • Start date: Oct 15, 2019 to Feb 15, 2020
    • Study completion date: Aug 31, 2022 to Feb 15, 2023
    v4
  7. Lead sponsor: University of Maryland to University of Maryland, Baltimorev3
  8. Start date: Jun 1, 2019 to Oct 15, 2019v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03909737
Lead Sponsor University of Maryland, Baltimore
Collaborators: Bill and Melinda Gates Foundation
Conditions
(from sponsor)		 Stillbirths and Infant Mortality
Related terms Infant Death, Stillbirth
Enrollment 99,700 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov