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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01235546
First Posted: November 5, 2010
Last Update Posted: July 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
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
Information provided by (Responsible Party):
Alan Tita, University of Alabama at Birmingham
November 4, 2010
November 5, 2010
March 13, 2017
July 28, 2017
July 28, 2017
May 2011
December 2015   (Final data collection date for primary outcome measure)
Participants With Endometritis and/or Wound Infection and/or Other Post-cesarean Infections (Occurring Within 6 Weeks of Delivery) [ Time Frame: Up to 6 weeks after delivery ]
Endometritis was defined as the presence of at least two of the following signs with no other recognized cause: fever (temperature of at least 38°C [100.4°F]), abdominal pain, uterine tenderness, or purulent drainage from the uterus. Wound infection was defined as the presence of either superficial or deep incisional surgical-site infection characterized by cellulitis or erythema and induration around the incision or purulent discharge from the incision site with or without fever and included necrotizing fasciitis. Wound hematoma, seroma, or breakdown alone in the absence of the preceding signs did not constitute infection.
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 ]
Complete list of historical versions of study NCT01235546 on ClinicalTrials.gov Archive Site
Not Provided
• 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 ]
  • Neonatal Morbidities (Listed Below) [ Time Frame: Up to 3 months after birth ]
    morbidities include: death, Respiratory Distress Syndrome (RDS), Bronchopulmonary Dysplasia (BPD), Periventricular Leukomalacia (PVL) suspected or proven sepsis, Necrotizing Enterocolitis (NEC) Intraventricular Hemorrhage (IVH) and systemic inflammatory response syndrome
  • Neonatal Intensive Care Unit (NICU) Admission [ Time Frame: Up to 3 months after birth ]
    Neonates who are admitted to the NICU due to morbidities diagnosed from birth and up to three months of life. Morbidities as defined in the Neonatal morbidities outcome measure.
  • Neonatal Readmission [ Time Frame: Up to 3 months after birth ]
  • Maternal Fever [ Time Frame: Up to 6 weeks after delivery ]
  • Maternal Postpartum Readmission or Unscheduled Visit [ Time Frame: Up to 6 weeks after delivery ]
    Maternal postpartum unscheduled visit or readmission to the hospital
  • Maternal Postpartum Antibiotic Use [ Time Frame: Up to 6 weeks after delivery ]
    Maternal postpartum use of antibiotics
  • Maternal Serious Adverse Events [ Time Frame: Up to 6 weeks after delivery ]
    All maternal serious adverse events
  • Neonatal Serious Adverse Events [ Time Frame: Up to 3 months after birth ]
    Composite for all neonatal serious adverse events
  • Infant Pyloric Stenosis [ Time Frame: up to 3 months after birth ]
    Any diagnosis of pyloric stenosis based on clinical presentation and radiological and/or surgical confirmation
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Endometritis
  • Wound Infection
  • Abscess
  • Surgical Site Infection
  • Drug: Azithromycin and standard of care
    500 mg in 250 cc normal saline 1 time dose plus standard of care (cephazolin or clindamycin)
    Other Name: Zithromax
  • Drug: Placebo and standard of care
    250 cc normal saline, plus standard of care (cephazolin or clindamycin)
    Other Name: normal saline
  • Placebo Comparator: Placebo and standard of care
    250 cc normal saline
    Intervention: Drug: Placebo and standard of care
  • Experimental: Azithromycin and Standard of care
    500 mg Azithromycin in 250 cc normal saline
    Intervention: Drug: Azithromycin and standard of care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2013
December 2015
December 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
Sexes Eligible for Study: Female
14 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01235546
F090323006
NIH 1R01HD064729-01A1 ( Other Grant/Funding Number: NICHD )
Yes
Not Provided
Plan to Share IPD: No
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
June 2017

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