Surgical Site Infection Clinical Trial
Official title:
Cesarean Section Optimal Antibiotic Prophylaxis Trial
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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