Study of Effectiveness and Safety of Azithromycin-based Extended-spectrum Prophylaxis to Prevent Post Cesarean Infection (C/SOAP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University of Alabama at Birmingham
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Alan Tita, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01235546
First received: November 4, 2010
Last updated: September 2, 2014
Last verified: September 2014

November 4, 2010
September 2, 2014
May 2011
January 2015   (final data collection date for primary outcome measure)
Composite of endometritis and/or wound infection and/or other post-cesarean infections (occurring within 4-6 weeks of delivery) [ Time Frame: 4-6 weeks after delivery ] [ Designated as safety issue: No ]
Composite of endometritis and/or wound infection and/or other post-cesarean infections (occurring within 4 weeks of delivery) [ Time Frame: 4 weeks after delivery ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01235546 on ClinicalTrials.gov Archive Site
• Individual post-cesarean infections: Endometritis, wound infection (including necrotizing fascitis), other infections including abscess, septic thrombosis, pneumonia, pyelonephritis and breast infection [ Time Frame: 4-6 weeks after delivery ] [ Designated as safety issue: No ]
• Individual post-cesarean infections: Endometritis, wound infection (including necrotizing fascitis), other infections including abscess, septic thrombosis, pneumonia, pyelonephritis and breast infection [ Time Frame: 4 weeks after delivery ] [ Designated as safety issue: No ]
  • Neonatal morbidities including death, RDS, BPD, PVL, suspected or proven sepsis, NEC, IVH [ Time Frame: Up to 3 months ] [ Designated as safety issue: Yes ]
  • Pyloric stenosis [ Time Frame: up to 3 months ] [ Designated as safety issue: Yes ]
  • Post-cesarean infection by chorioamnionic colonization with ureaplasmas [ Time Frame: 4-6 weeks ] [ Designated as safety issue: No ]
    Does the impact of extended regimen vary by the presence or absence of ureaplasmas at randomization?
  • Effect modifiers [ Time Frame: 4-6 weeks ] [ Designated as safety issue: No ]
    Does the impact of extended prophylaxis vary by specific factors including obesity, wound size, duration from administration to incision
Not Provided
 
Study of Effectiveness and Safety of Azithromycin-based Extended-spectrum Prophylaxis to Prevent Post Cesarean Infection
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Endometritis
  • Wound Infection
  • Abscess
  • Surgical Site Infection
  • Drug: Azithromycin
    500 mg in 250 cc normal saline 1 time dose
  • Drug: Placebo
    250 cc normal saline
  • Placebo Comparator: Placebo
    250 cc normal saline
    Intervention: Drug: Placebo
  • Experimental: Azithromycin
    Intervention: Drug: Azithromycin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2000
July 2015
January 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

-

Pregnant Women aged 14 years and over at ≥ 24 weeks' viable gestation who will undergo unscheduled/non-elective cesareans with either:

  1. Labor (spontaneous or induced): active labor (ongoing contractions and at least 4cm dilated or contractions for at least 4 hours with documented cervical change of ≥1cm dilatation or ≥50% effacement), or
  2. Membrane rupture (standardized to duration of at least 4 hours prior to randomization).

Exclusion Criteria:

  • Patient unwilling or unable to provide consent
  • Multiple pregnancy
  • Known azithromycin (or other macrolide) allergy
  • Vaginal delivery
  • Elective or scheduled cesarean prior to labor or membrane rupture.
  • Azithromycin, erythromycin or other macrolide antibiotic use within 7 days of enrollment.
  • Clinical chorioamnionitis or any other active bacterial infection (e.g. pyelonephritis, pneumonia, abscess) at time of randomization.
  • Patient is unable or unlikely to follow-up after delivery (e.g. no prenatal care or a non-resident patient)
  • Fetal demise or major congenital anomaly
  • Significant liver disease defined as known cirrhosis or elevated transaminases of at least 3-fold upper limit of normal
  • Significant renal disease defined as serum creatinine known to be >2.0 mg/dl or on dialysis.
  • Active congestive heart failure (EF<45%) or pulmonary edema
  • Active diarrhea at time of delivery
  • Any patient with significant electrolyte abnormalities such as hypokalemia or hypocalcemia
  • Any patient with structural heart disease or arrhythmias, or taking any medications known to prolong the QT interval
  • Patient currently being treated with efavirenz, nelfinavir or fluconazole
Female
14 Years and older
No
Contact: Alan TN Tita, MD, PhD 205-934-42565 atita@uab.edu
Contact: Rachel C LeDuke, MSN 205-934-5509 rcopper@uab.edu
United States
 
NCT01235546
F090323006, 1R01HD064729-01A1
Yes
Alan Tita, University of Alabama at Birmingham
Alan Tita
  • Eunice 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
Principal Investigator: Alan TN Tita, MD, PhD University of Alabama at Birmingham
University of Alabama at Birmingham
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP