Azithromycin-Prevention in Labor Use Study (A-PLUS)

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.

Conditions

• Maternal Death
• Maternal Infections Affecting Fetus or Newborn
• Neonatal SEPSIS
• Maternal Sepsis During Labor
• Neonatal Death
• Postpartum Sepsis

Interventions

DRUG

Azithromycin

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.

DRUG

Placebo

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

Sponsors & Collaborators

• University of Alabama at Birmingham

  collaborator OTHER

• University Teaching Hospital, Lusaka, Zambia

  collaborator OTHER

• University of North Carolina, Chapel Hill

  collaborator OTHER

• Kinshasa School of Public Health

  collaborator OTHER

• University of Colorado, Denver

  collaborator OTHER

• Institute of Nutrition of Central America and Panama

  collaborator OTHER

• University of Virginia

  collaborator OTHER

• International Centre for Diarrhoeal Disease Research, Bangladesh

  collaborator OTHER

• Thomas Jefferson University

  collaborator OTHER

• Columbia University

  collaborator OTHER

• Aga Khan University

  collaborator OTHER

• Boston University

  collaborator OTHER

• Lata Medical Research Foundation, Nagpur

  collaborator OTHER

• Indiana University School of Medicine

  collaborator OTHER

• Moi Univeristy

  collaborator OTHER

• RTI International

  collaborator OTHER

• Bill and Melinda Gates Foundation

  collaborator OTHER

• Jawaharlal Nehru Medical College

  collaborator OTHER

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• NICHD Global Network for Women's and Children's Health

  lead NETWORK

Principal Investigators

• Marion Koso-Thomas, MD · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-09-01

Primary Completion

2022-09-30

Completion

2022-09-30

Countries

• Bangladesh
• Democratic Republic of the Congo
• Guatemala
• India
• Kenya
• Pakistan
• Zambia

Study Locations