Ignite Creation Date:
2024-05-06 @ 1:00 PM
Last Modification Date:
2024-10-26 @ 1:07 PM
Study NCT ID:
NCT03909737
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-30
First Post:
2019-02-26
Brief Title:
Oral Azithromycin to Prevent Stillbirths and Infant Mortality in Mali
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Sauver Avec lAzithromycine en Traitant Les Femmes Enceintes et Les Enfants SANTE
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SANTE
Brief Summary:
The double blind randomized controlled trial will assess the efficacy of oral azithromycin administered to pregnant women andor 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 andor 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 Malis 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None