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

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. The research is conducted in partnership with the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) via their 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.

Researchers will study the effectiveness and safety of a single oral dose of intrapartum azithromycin compared to placebo (plus standard care) in reducing the risk of neonatal and maternal sepsis or death in laboring women. If the results are positive, the investigators will facilitate the change in practice at participating sites and approach the WHO and pertinent professional organizations to consider guideline updates.

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 a targeted sub-population of those women at the highest risk for infection because they have prolonged labor (218 hours) and/or prolonged membrane rupture (28 hours).
  • Study whether a successful prophylaxis intervention is likely to reduce infections and death and may reduce the need for prolonged antibiotic therapy and associated health care costs of treating drug resistant infections.

Results & Accomplishments

Media

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

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 Jawaharal Nehru Medical College (Belagavi, India)
University of Alabama at Birmingham – with the University of Zambia, Department of Paediatrics & 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 Diarrhoeal Disease Research (Bangladesh)

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

FNIH Contact

Susan Wiener, Senior Program Manager, swiener@fnih.org