Azithromycin-Prevention in Labor Use Study (A-PLUS)
Status:
Recruiting
Trial end date:
2023-09-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
NICHD Global Network for Women's and Children's Health
Collaborators:
Aga Khan University Bill and Melinda Gates Foundation Boston University Columbia University INCAP, Guatemala Indiana University School of Medicine Institute of Nutrition of Central America and Panama International Centre for Diarrhoeal Disease Research, Bangladesh Kinshasa School of Public Health KLE University's J N Medical College KLE University's Jawaharlal Nehru Medical College Lata Medical Research Foundation Lata Medical Research Foundation, Nagpur Moi Univeristy RTI International Thomas Jefferson University University of Alabama at Birmingham University of Colorado, Denver University of North Carolina, Chapel Hill University of Virginia University Teaching Hospital, Lusaka, Zambia