CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 58,747 enrolled
Drug / intervention
Azithromycin +1 moredrug
Likely dose
Azithromycin 2 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03871491
NCT03871491Phase 3Completed
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Prevention of Maternal and Neonatal Death/Infections With a Single Oral Dose of Azithromycin in Women in Labor (in Low- and Middle-income Countries): a Randomized Controlled Trial

NICHD Global Network for Women's and Children's Health·interventional·Posted Mar 12, 2019·Updated Oct 24, 2024

In Brief

A Phase 3 clinical trial evaluating Azithromycin and Placebo for Maternal Death and 5 related conditions. Completed, enrolled 58,747 participants across 8 sites in 7 countries.

Detailed Summary

Maternal and neonatal infections are among the most frequent causes of maternal and neonatal deaths, and current antibiotic strategies have not been effective in preventing many of these deaths. Recently, a randomized clinical trial conducted in a single site in The Gambia showed that treatment with oral dose of 2 g azithromycin vs. placebo for all women in labor reduced selected maternal and neonatal infections. However, it is unknown if this therapy reduces maternal and neonatal sepsis and mortality. The A-PLUS trial includes two primary hypotheses, a maternal hypothesis and a neonatal hypothesis. First, a single, prophylactic intrapartum oral dose of 2 g azithromycin given to women in labor will reduce maternal death or sepsis. Second, a single, prophylactic intrapartum oral dose of 2 g azithromycin given to women in labor will reduce intrapartum/neonatal death or sepsis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMaternal Death, Maternal Infections Affecting Fetus or Newborn, Neonatal SEPSIS, Maternal Sepsis During Labor, Neonatal Death, Postpartum Sepsis
CountriesBangladesh, Democratic Republic of the Congo, Guatemala, India, Kenya, Pakistan, Zambia
CollaboratorsUniversity of Alabama at Birmingham, University Teaching Hospital, Lusaka, Zambia, University of North Carolina, Chapel Hill, Kinshasa School of Public Health, University of Colorado, Denver, Institute of Nutrition of Central America and Panama, University of Virginia, International Centre for Diarrhoeal Disease Research, Bangladesh, Thomas Jefferson University, Columbia University, Aga Khan University, Boston University, Lata Medical Research Foundation, Nagpur, Indiana University, Moi Univeristy, RTI International, Bill and Melinda Gates Foundation, Jawaharlal Nehru Medical College, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedMar 12, 2019
Enrollment StartSep 1, 2020
Primary CompletionSep 30, 2022
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 7.3 years ago

Interventions

Azithromycindrug

The study intervention is a single 2 g dose of directly observed oral azithromycin, to be administered as four 500 mg pills or tablets directly after randomization. By random allocation, participants will receive 2 g of oral azithromycin.

Placebodrug

Identical appearing placebo, administered as a single oral dose directly after randomization.