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

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.
 
ClinicalTrials.gov Identifier: NCT01235546
Recruitment Status : Completed
First Posted : November 5, 2010
Results First Posted : July 28, 2017
Last Update Posted : July 28, 2017
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

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Endometritis Wound Infection Abscess Surgical Site Infection Drug: Azithromycin and standard of care Drug: Placebo and standard of care Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2013 participants
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
Study Start Date : May 2011
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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:
  1. 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

  2. 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.

  3. Neonatal Readmission [ Time Frame: Up to 3 months after birth ]
  4. Maternal Fever [ Time Frame: Up to 6 weeks after delivery ]
  5. Maternal Postpartum Readmission or Unscheduled Visit [ Time Frame: Up to 6 weeks after delivery ]
    Maternal postpartum unscheduled visit or readmission to the hospital

  6. Maternal Postpartum Antibiotic Use [ Time Frame: Up to 6 weeks after delivery ]
    Maternal postpartum use of antibiotics

  7. Maternal Serious Adverse Events [ Time Frame: Up to 6 weeks after delivery ]
    All maternal serious adverse events

  8. Neonatal Serious Adverse Events [ Time Frame: Up to 3 months after birth ]
    Composite for all neonatal serious adverse events

  9. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01235546


Locations
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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
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Principal Investigator: Alan TN Tita, MD, PhD University of Alabama at Birmingham
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Alan Tita, Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01235546    
Other Study ID Numbers: F090323006
NIH 1R01HD064729-01A1 ( Other Grant/Funding Number: NICHD )
First Posted: November 5, 2010    Key Record Dates
Results First Posted: July 28, 2017
Last Update Posted: July 28, 2017
Last Verified: June 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:
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Infections
Communicable Diseases
Surgical Wound Infection
Wound Infection
Endometritis
Disease Attributes
Pathologic Processes
 Postoperative Complications
Pelvic Inflammatory Disease
Adnexal Diseases
Uterine Diseases
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents