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RECRUITING
NCT06605118
PHASE3

Azithromycin Prophylaxis for PRElabor CEsarean DElivery Trial

Sponsor: The George Washington University Biostatistics Center

View on ClinicalTrials.gov

Summary

This is a phase-III multi-center double-blind randomized controlled trial of 8,000 individuals undergoing a scheduled or prelabor cesarean delivery who are randomized to either adjunctive azithromycin prophylaxis or to placebo. Both groups also will receive standard of care preoperative antibiotics (excluding azithromycin). The primary endpoint is a maternal infection composite defined as any one of the following up to 6 weeks postpartum: endometritis, wound infection, abscess, septic thrombosis, sepsis, pneumonia, pyelonephritis and breast infection.

Official title: Azithromycin Prophylaxis for Prelabor Cesarean Delivery Trial

Key Details

Gender

FEMALE

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

8000

Start Date

2024-11-06

Completion Date

2027-11-30

Last Updated

2026-04-09

Healthy Volunteers

Yes

Interventions

DRUG

Azithromycin Injection

500mg azithromycin in 250 mL of normal saline

DRUG

Placebo

250 mL of normal saline

DRUG

Standard of Care Preoperative antibiotics

standard of care preoperative antibiotics (excluding azithromycin) prior to incision

Locations (14)

University of Alabama - Birmingham

Birmingham, Alabama, United States

Regents of the University of California San Francisco

San Francisco, California, United States

Northwestern University

Chicago, Illinois, United States

Columbia University

New York, New York, United States

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, United States

Duke University

Durham, North Carolina, United States

Case Western Reserve University

Cleveland, Ohio, United States

Ohio State University

Columbus, Ohio, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Magee Women's Hospital

Pittsburgh, Pennsylvania, United States

Brown Univeristy

Providence, Rhode Island, United States

Baylor College of Medicine

Houston, Texas, United States

University of Texas - Houston

Houston, Texas, United States

University of Utah

Salt Lake City, Utah, United States