Azithromycin Prophylaxis for Prelabor Cesarean Delivery Trial
Status: Recruiting
Location: See all (14) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: Female
Healthy Volunteers: t
View:
• ≥ 23 weeks' gestation (ACOG dating criteria)
• Scheduled or prelabor cesarean delivery
• Singleton or twin gestation
Locations
United States
Alabama
University of Alabama - Birmingham
RECRUITING
Birmingham
California
Regents of the University of California San Francisco
RECRUITING
San Francisco
Illinois
Northwestern University
RECRUITING
Chicago
North Carolina
University of North Carolina - Chapel Hill
RECRUITING
Chapel Hill
Duke University
RECRUITING
Durham
New York
Columbia University
RECRUITING
New York
Ohio
Case Western Reserve University
RECRUITING
Cleveland
Ohio State University
RECRUITING
Columbus
Pennsylvania
Hospital of the University of Pennsylvania
RECRUITING
Philadelphia
Magee Women's Hospital
RECRUITING
Pittsburgh
Rhode Island
Brown Univeristy
RECRUITING
Providence
Texas
Baylor College of Medicine
RECRUITING
Houston
University of Texas - Houston
RECRUITING
Houston
Utah
University of Utah
RECRUITING
Salt Lake City
Contact Information
Primary
Rebecca G Clifton, PhD
rclifton@bsc.gwu.edu
301-881-9260
Backup
Steven Weiner, MS
weiner@bsc.gwu.edu
Time Frame
Start Date: 2024-11-04
Estimated Completion Date: 2028-03-31
Participants
Target number of participants: 8000
Treatments
Experimental: Azithromycin prophylaxis and standard of care preoperative antibiotics
500mg of intravenous azithromycin administered up to 1 hour prior to cesarean incision (or as soon as feasible after incision) and infused over one hour per FDA infusion recommendations for azithromycin. Additionally patients will received standard of care preoperative antibiotics (excluding azithromycin) prior to incision.
Placebo_comparator: Placebo and standard of care preoperative antibiotics
Normal saline administered up to 1 hour prior to cesarean incision (or as soon as feasible after incision) and infused over one hour in addition to standard of care preoperative antibiotics (excluding azithromycin) prior to incision.
Related Therapeutic Areas
Sponsors
Collaborators: University of Alabama at Birmingham, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Leads: The George Washington University Biostatistics Center