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

PHASE3CompletedINTERVENTIONAL
Enrollment

58,747

Participants

Timeline

Start Date

September 1, 2020

Primary Completion Date

September 30, 2022

Study Completion Date

September 30, 2022

Conditions
Maternal DeathMaternal Infections Affecting Fetus or NewbornNeonatal SEPSISMaternal Sepsis During LaborNeonatal DeathPostpartum 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.

Trial Locations (8)

1212

ICDDRB, Dhaka

30100

Moi University School of Medicine, Eldoret

74800

The Aga Khan University, Karachi

Unknown

Kinshasa School of Public Health, Kinshasa

Lata Medical Research Foundation, Nagpur

University Teaching Hospital, Lusaka

01011

Institute for Nutrition of Central America and Panama (INCAP), Guatemala City

590 010

Jawaharlal Nehru Medical College, Belagām

All Listed Sponsors
collaborator

University of Alabama at Birmingham

OTHER

collaborator

University Teaching Hospital, Lusaka, Zambia

OTHER

collaborator

University of North Carolina, Chapel Hill

OTHER

collaborator

Kinshasa School of Public Health

OTHER

collaborator

University of Colorado, Denver

OTHER

collaborator

Institute of Nutrition of Central America and Panama

OTHER

collaborator

University of Virginia

OTHER

collaborator

International Centre for Diarrhoeal Disease Research, Bangladesh

OTHER

collaborator

Thomas Jefferson University

OTHER

collaborator

Columbia University

OTHER

collaborator

Aga Khan University

OTHER

collaborator

Boston University

OTHER

collaborator

Lata Medical Research Foundation, Nagpur

OTHER

collaborator

Indiana University School of Medicine

OTHER

collaborator

Moi Univeristy

OTHER

collaborator

RTI International

OTHER

collaborator

Bill and Melinda Gates Foundation

OTHER

collaborator

Jawaharlal Nehru Medical College

OTHER

collaborator

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

NIH

lead

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

NETWORK

NCT03871491 - Azithromycin-Prevention in Labor Use Study (A-PLUS) | Biotech Hunter | Biotech Hunter