NCT01235546

Study of Effectiveness and Safety of Azithromycin-based Extended-spectrum Prophylaxis to Prevent Post Cesarean Infection

Cesarean Section Optimal Antibiotic Prophylaxis Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,013 (actual)
• Sponsor: Alan Tita · Academic / Other
• Sex: Female
• Age: 14 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Endometritis
• Wound Infection
• Abscess
• Surgical Site Infection

Interventions

Type	Name	Description
DRUG	Azithromycin and standard of care	500 mg in 250 cc normal saline 1 time dose plus standard of care (cephazolin or clindamycin)
DRUG	Placebo and standard of care	250 cc normal saline, plus standard of care (cephazolin or clindamycin)

Timeline

• Start date: 2011-05-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2010-11-05
• Last updated: 2017-07-28
• Results posted: 2017-07-28

Locations

9 sites across 1 country: United States