Oral Azithromycin to Prevent Stillbirths and Infant Mortality in Mali

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

99700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-24

Study Completion Date

2026-03-31

Brief Summary

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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.

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Detailed Description

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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 and/or 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, Mali's 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.

Conditions

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Stillbirths and Infant Mortality

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

This study will enroll three study cohorts: (1) a rural cohort of pregnant mother-infant pairs based in the southern region of Sikasso where infant mortality rates are higher than the national average (2) a rural cohort of only infants enrolled from the same communities as the mother-infant pairs, and (3) an urban cohort of pregnant mother-infant pairs based in Bamako. Cohort 1 will use a 2x2 factorial design. The pregnant women will be randomized to receive either oral azithromycin or placebo, and their infants, once born, will be separately randomized to receive either oral azithromycin or placebo. Cohorts 2 and 3 will use a parallel design. In Cohort 2, infants will be randomized to either azithromycin or placebo. In Cohort 3, mother-infant pairs will be randomized in tandem to either azithromycin or placebo.

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Intervention Type OTHER

No intervention to pregnant women

Interventions

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Azithromycin to pregnant women

Azithromycin to pregnant women at antenatal care visits and during delivery

Intervention Type DRUG

Azithromycin to infants

Azithromycin to infants at 6 and 14 week EPI visits

Intervention Type DRUG

Placebo to pregnant women

Placebo to pregnant women at antenatal care visits and during delivery

Intervention Type OTHER

Placebo to infants

Placebo to infants at 6 and 14 week EPI visits

Intervention Type OTHER

No intervention to pregnant women

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Pregnant women:

1. Participant is attending an ANC visit between 13 and 37 weeks gestation, with gestational age estimated using fundal height measurements and/or maternal report of quickening, at a participating health facility.
2. Participant is able to understand and comply with planned study procedures.
3. Participant has provided informed consent prior to initiation of any study procedures.
4. Participant intends to reside in the study area until her newborn infant is at least 12 months old.

Infants:

1. Infant is \<12 mo attending a DTP-1 routine vaccination visit at a participating health facility.
2. Parent or guardian is able to understand and comply with planned study procedures.
3. Parent or guardian has provided informed consent prior to initiation of any study procedures.
4. Parent or guardian intends to reside in the study area until participant is at least 12 months old.

Exclusion Criteria

1. Allergy to macrolides or azalides.
2. Any condition that, in the opinion of the investigator, might compromise the well-being of the participant or compliance with study procedures.
3. Medical treatment that requires administration of azithromycin (this can be a temporary exclusion if the drug is later discontinued).

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes