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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:
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
ClinicalTrials.gov Identifier:
NCT01235546
First received: November 4, 2010
Last updated: June 29, 2017
Last verified: June 2017
  Purpose

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.


Condition Intervention
Endometritis Wound Infection Abscess Surgical Site Infection Drug: Azithromycin and standard of care Drug: Placebo and standard of care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Cesarean Section Optimal Antibiotic Prophylaxis Trial

Resource links provided by NLM:


Further study details as provided by Alan Tita, University of Alabama at Birmingham:

Primary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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


Enrollment: 2013
Study Start Date: May 2011
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo and standard of care
250 cc normal saline
Drug: Placebo and standard of care
250 cc normal saline, plus standard of care (cephazolin or clindamycin)
Other Name: normal saline
Experimental: Azithromycin and Standard of care
500 mg Azithromycin in 250 cc normal saline
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

  Eligibility

Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01235546

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, New York
Columbia University
New York, New York, United States, 10032
United States, North Carolina
Mission Hospital
Asheville, North Carolina, United States, 28801
University of North Carolina
Chapel Hill, North Carolina, United States, 27599-7516
United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0587
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77225
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
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
Investigators
Principal Investigator: Alan TN Tita, MD, PhD University of Alabama at Birmingham
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alan Tita, Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01235546     History of Changes
Other Study ID Numbers: F090323006
NIH 1R01HD064729-01A1 ( Other Grant/Funding Number: NICHD )
Study First Received: November 4, 2010
Results First Received: March 13, 2017
Last Updated: June 29, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Alan Tita, University of Alabama at Birmingham:
Pregnancy
Cesarean section
Antibiotic
Infections

Additional relevant MeSH terms:
Infection
Communicable Diseases
Wound Infection
Surgical Wound Infection
Endometritis
Wounds and Injuries
Postoperative Complications
Pathologic Processes
Pelvic Inflammatory Disease
Adnexal Diseases
Genital Diseases, Female
Uterine Diseases

ClinicalTrials.gov processed this record on August 17, 2017