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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
Results First Submitted: March 13, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Endometritis
Wound Infection
Abscess
Surgical Site Infection
Interventions: Drug: Azithromycin and standard of care
Drug: Placebo and standard of care

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were randomly assigned to receive either azithromycin (at a dose of 500mg in 250 ml of saline, one time dose) or an identical-appearing saline placebo and the standard of care (cephazolin or clindamycin)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The addition of azithromycin and the standard of care (cephazolin or clindamycin) for antibiotic prophylaxis before cesarean delivery may further reduce the rate of postoperative infection. We evaluated the benefits and safety of azithromycin prophylaxis and the standard of care in women undergoing nonelective cesarean section.

Reporting Groups
  Description
Placebo and Standard of Care Placebo: 250 cc normal saline Standard of care (cephazolin or clindamycin)
Azithromycin and Standard of Care Azithromycin: 500 mg in 250 cc normal saline 1 time dose and standard of care (cephazolin or clindamycin)

Participant Flow:   Overall Study
    Placebo and Standard of Care   Azithromycin and Standard of Care
STARTED   994   1019 
COMPLETED   992   1018 
NOT COMPLETED   2   1 
Staff error, medication not administered                1                0 
Protocol Violation                1                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo With Standard Prophylaxis Placebo: 250 cc normal saline Standard Prophylaxis: standard cephalosporin prophylaxis
Azithromycin (Zithromax) With Standard Prophylaxis Azithromycin: 500 mg in 250 cc normal saline 1 time dose Standard Prophylaxis: standard cephalosporin prophylaxis
Total Total of all reporting groups

Baseline Measures
   Placebo With Standard Prophylaxis   Azithromycin (Zithromax) With Standard Prophylaxis   Total 
Overall Participants Analyzed 
[Units: Participants]
 994   1019   2013 
Age 
[Units: Years]
Median (Standard Deviation)
 28.4  (6.5)   28.2  (6.1)   28.3  (6.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      994 100.0%      1019 100.0%      2013 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   994   1019   2013 
Smoking Prevalence 
[Units: Participants]
Count of Participants
 122   97   219 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Other Pre-specified:   Neonatal Morbidities (Listed Below)   [ Time Frame: Up to 3 months after birth ]

3.  Other Pre-specified:   Neonatal Intensive Care Unit (NICU) Admission   [ Time Frame: Up to 3 months after birth ]

4.  Other Pre-specified:   Neonatal Readmission   [ Time Frame: Up to 3 months after birth ]

5.  Other Pre-specified:   Maternal Fever   [ Time Frame: Up to 6 weeks after delivery ]

6.  Other Pre-specified:   Maternal Postpartum Readmission or Unscheduled Visit   [ Time Frame: Up to 6 weeks after delivery ]

7.  Other Pre-specified:   Maternal Postpartum Antibiotic Use   [ Time Frame: Up to 6 weeks after delivery ]

8.  Other Pre-specified:   Maternal Serious Adverse Events   [ Time Frame: Up to 6 weeks after delivery ]

9.  Other Pre-specified:   Neonatal Serious Adverse Events   [ Time Frame: Up to 3 months after birth ]

10.  Other Pre-specified:   Infant Pyloric Stenosis   [ Time Frame: up to 3 months after birth ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Alan Tita, MD
Organization: University of Alabama at Birmingham, Maternal & Fetal Medicine
phone: 205-934-9616
e-mail: atita@uab.edu


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

Responsible Party: Alan Tita, 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 )
First Submitted: November 4, 2010
First Posted: November 5, 2010
Results First Submitted: March 13, 2017
Results First Posted: July 28, 2017
Last Update Posted: July 28, 2017