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

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

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)

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• University of Texas

  collaborator OTHER

• University of North Carolina

  collaborator OTHER

• Mission Hospital

  collaborator UNKNOWN

• Ochsner Health System

  collaborator OTHER

• The University of Texas Health Science Center, Houston

  collaborator OTHER

• Columbia University

  collaborator OTHER

• University of Utah

  collaborator OTHER

• University of Mississippi Medical Center

  collaborator OTHER

• Alan Tita

  lead OTHER

Principal Investigators

• Alan TN Tita, MD, PhD · University of Alabama at Birmingham

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

14 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-05-31

Primary Completion

2015-12-31

Completion

2015-12-31

Countries

• United States

Study Locations