Multi-site Efficacy and Safety Trial of Intrapartum Azithromycin in Low- and Middle-Income Countries

Protecting laboring mothers and newborns against neonatal and maternal sepsis and death

The Problem
Clinicians lack proven strategies that can effectively prevent neonatal/maternal sepsis and death during childbirth.
The Solution
The A-Plus study will determine the effectiveness of a single oral dose of azithromycin in reducing the risk of neonatal/maternal sepsis and death during childbirth.

Overview

The Multi-site Efficacy and Safety Trial of Intrapartum Azithromycin in Low- and Middle-Income Countries (A-Plus) study will assess low-cost, sustainable interventions to improve maternal and child health. It is being conducted in partnership with the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) via its Global Network for Women's and Children's Health Research, which supports and conducts clinical trials in low- and middle-income countries by pairing foreign and U.S. investigators. The study is funded through a grant from the Bill & Melinda Gates Foundation to the FNIH.

A-Plus researchers will study the safety and effectiveness of a single oral dose of intrapartum azithromycin compared to placebo (both in addition to standard of care) in reducing the risk of neonatal and maternal sepsis or death in laboring women. If the results are positive, then A-Plus investigators will facilitate the shift in standard practice at participating sites and approach the World Health Organization (WHO) and pertinent professional organizations to encourage them to update their care guidelines.

Goals

  • Evaluate the role of a single oral dose of azithromycin (plus usual care) to prevent maternal death or peripartum sepsis and intrapartum/neonatal death or sepsis in laboring women as well as in a targeted sub-population of women at the highest risk for infection (i.e., because they have prolonged labor of 218 hours, and/or prolonged membrane rupture of 28 hours).
  • Study whether a successful prophylaxis intervention significantly reduces the rate of infections and deaths, as well as the need for prolonged antibiotic therapy and associated costs of treating drug- resistant infections.

Media

FNIH Announcement (June 3, 2020): FNIH Launches Project Testing Antibiotic to Prevent Infections in Mothers and Newborns Read more

Partners

Public-Sector Partners

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

Private-Sector Partners

  • Bill & Melinda Gates Foundation*
  • RTI International

Academic Partners

  • Boston University – with Lata Medical Research Foundation (Nagpur, India)
  • Columbia University – with the Aga Khan University (Pakistan)
  • Indiana University School of Medicine – with Moi University (Kenya)
  • Thomas Jefferson University – with the Department of Medical Education Jawaharlal Nehru Medical College (Belagavi, India)
  • University of Alabama at Birmingham – with the University of Zambia, Department of Pediatrics & Child Health University Teaching Hospital (Zambia)
  • University of Colorado, Denver – with the Institute of Nutrition of Central America and Panama (Guatemala)
  • University of North Carolina at Chapel Hill – with the Kinshasa School of Public Health (Democratic Republic of Congo)
  • University of Virginia – with the International Center for Diarrheal Disease Research (Bangladesh)

*Provided financial or in-kind support for this program.

 

FNIH Contacts

  • Susan Wiener, Senior Project Manager, swiener@fnih.org
  • Renata Hoffstetter, Associate Project Manager, rhoffstetter@fnih.org