CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,013 enrolled
Drug / intervention
Azithromycin and standard of care +1 moredrug
Likely dose
Azithromycin and standard of care 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01235546
NCT01235546N/ACompleted
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Cesarean Section Optimal Antibiotic Prophylaxis Trial

Alan Tita·interventional·Posted Nov 5, 2010·Updated Jul 28, 2017

In Brief

A clinical study evaluating Azithromycin and standard of care and Placebo and standard of care for Endometritis and 3 related conditions. Completed, enrolled 2,013 participants across 9 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEndometritis, Wound Infection, Abscess, Surgical Site Infection
CountriesUnited States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Texas, University of North Carolina, Mission Hospital, Ochsner Health System, The University of Texas Health Science Center, Houston, Columbia University, University of Utah, University of Mississippi Medical Center

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 5, 2010
Enrollment StartMay 1, 2011
Primary CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 15.7 years ago

Interventions

Azithromycin and standard of caredrug

500 mg in 250 cc normal saline 1 time dose plus standard of care (cephazolin or clindamycin)

Placebo and standard of caredrug

250 cc normal saline, plus standard of care (cephazolin or clindamycin)