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Azithromycin Prophylaxis for PRElabor CEsarean DElivery Trial
Sponsor: The George Washington University Biostatistics Center
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
Azithromycin Injection
500mg azithromycin in 250 mL of normal saline
Placebo
250 mL of normal saline
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