Antenatal, intrapartum and infant azithromycin to prevent stillbirths and infant deaths: study protocol for SANTE, a 2×2 factorial randomised controlled trial in Mali.

Publication date: Aug 30, 2023

In high mortality settings, prophylactic azithromycin has been shown to improve birth weight and gestational age at birth when administered antenatally, to reduce the incidence of neonatal infections when administered intrapartum, and to improve survival when administered in infancy. Questions remain regarding whether azithromycin can prevent stillbirths, and regarding the optimal strategy for the delivery of azithromycin to pregnant women and their infants. Sauver avec l’Azithromycine en Traitant les Femmes Enceintes et les Enfants (SANTE) is a 2cD72 factorial, individually randomised, placebo-controlled, double-masked trial in rural Mali. The primary aims are: (1A) to assess the efficacy of antenatal and intrapartum azithromycin on a composite outcome of stillbirths and infant mortality through 6-12 months and (1B) to assess the efficacy of azithromycin administered concurrently with the first and third doses of pentavalent vaccines (Penta-1/3) on infant mortality through 6-12 months. Pregnant participants (n=49 600) and their infants are randomised 1:1:1:1 to one of four treatment arms: (1) mother and infant receive azithromycin, (2) mother and infant receive placebo, (3) mother receives azithromycin and infant receives placebo or (4) mother receives placebo and infant receives azithromycin. Pregnant participants receive three single 2 g doses: two antepartum and one intrapartum. Infants receive a single 20 mg/kg dose at the Penta-1 and 3 visits. An additional cohort of 12 000 infants is recruited at the Penta-1 visit and randomised 1:1 to receive azithromycin or placebo at the same time points. The SANTE trial will inform guidelines and policies regarding the administration of antenatal and infant azithromycin using routine healthcare delivery platforms. This trial was approved by the Institutional Review Board at the University of Maryland School of Medicine (Protocol #HP-00084242) and the FacultcE9 de McE9decine et d’Odonto-Stomatologie in Mali. The findings of this trial will be published in open access peer-reviewed journals. NCT03909737.

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Concepts Keywords


Type Source Name
drug DRUGBANK Azithromycin
disease MESH stillbirths
disease MESH infant deaths
disease VO protocol
disease MESH infections
disease VO pregnant women
drug DRUGBANK Pentaerythritol tetranitrate
disease VO dose
disease VO time
disease MESH causes
drug DRUGBANK Albendazole
disease MESH death
disease MESH neonatal deaths
disease IDO intervention
drug DRUGBANK Coenzyme M
disease MESH diphtheria
disease MESH tetanus
disease MESH pertussis
pathway KEGG Pertussis
disease MESH hepatitis
disease VO vaccine
disease IDO country
disease VO vaccination
drug DRUGBANK Trestolone
drug DRUGBANK Diethylstilbestrol
disease MESH violence
disease MESH live births
disease MESH Malaria
pathway KEGG Malaria
drug DRUGBANK Sulfadoxine
drug DRUGBANK Pyrimethamine
disease VO monthly
drug DRUGBANK Amodiaquine
disease VO Optaflu
disease IDO facility
disease MESH allergic reaction
disease IDO algorithm
drug DRUGBANK Etoperidone
disease VO Imovax ID

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