Study of Effectiveness and Safety of Azithromycin-based Extended-spectrum Prophylaxis to Prevent Post Cesarean Infection
Status:
Completed
Trial end date:
2015-12-01
Target enrollment:
Participant gender:
Summary
The Cesarean Section Optimal Antibiotic Prophylaxis (C/SOAP) study is a large pragmatic
multi-center randomized clinical trial designed to evaluate the comparative effectiveness and
safety of azithromycin-based extended-spectrum antibiotic prophylaxis (azithromycin plus
standard narrow-spectrum cephalosporin) relative to standard single-agent cephalosporin
(preferably prior to surgical incision) to prevent post-cesarean infection.
Hypothesis: Compared to narrow-spectrum prophylaxis (i.e. cefazolin alone, or clindamycin if
cephalosporin allergy) prior to surgical incision, the addition of extended-spectrum
prophylaxis (azithromycin + cefazolin) reduces the incidence of post-cesarean infection.
Phase:
N/A
Details
Lead Sponsor:
Alan Tita
Collaborators:
Columbia University Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Mission Hospital Ochsner Health System The University of Texas Health Science Center, Houston University of Mississippi Medical Center University of North Carolina University of Texas University of Utah