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Trial record 12 of 20 for:    "Endometritis" | "Anti-Bacterial Agents"

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

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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 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
Enrollment 2013
Recruitment Details 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 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.
Arm/Group Title Placebo and Standard of Care Azithromycin and Standard of Care
Hide Arm/Group Description Placebo: 250 cc normal saline Standard of care (cephazolin or clindamycin) Azithromycin: 500 mg in 250 cc normal saline 1 time dose and standard of care (cephazolin or clindamycin)
Period Title: Overall Study
Started 994 1019
Completed 992 1018
Not Completed 2 1
Reason Not Completed
Staff error, medication not administered             1             0
Protocol Violation             1             1
Arm/Group Title Placebo With Standard Prophylaxis Azithromycin (Zithromax) With Standard Prophylaxis Total
Hide Arm/Group Description Placebo: 250 cc normal saline Standard Prophylaxis: standard cephalosporin prophylaxis Azithromycin: 500 mg in 250 cc normal saline 1 time dose Standard Prophylaxis: standard cephalosporin prophylaxis Total of all reporting groups
Overall Number of Baseline Participants 994 1019 2013
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Standard Deviation)
Unit of measure:  Years
Number Analyzed 994 participants 1019 participants 2013 participants
28.4  (6.5) 28.2  (6.1) 28.3  (6.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 994 participants 1019 participants 2013 participants
Female
994
 100.0%
1019
 100.0%
2013
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 994 participants 1019 participants 2013 participants
994 1019 2013
Smoking Prevalence  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 994 participants 1019 participants 2013 participants
122
  12.3%
97
   9.5%
219
  10.9%
1.Primary Outcome
Title Participants With Endometritis and/or Wound Infection and/or Other Post-cesarean Infections (Occurring Within 6 Weeks of Delivery)
Hide Description 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.
Time Frame Up to 6 weeks after delivery
Hide Outcome Measure Data
Hide Analysis Population Description
The specific characteristics related to the cesarean delivery, including indications for cesarean delivery, receipt of standard prophylaxis, timing of receipt of study medication, and type of surgical skin preparation, were similar in the two groups.
Arm/Group Title Placebo Azithromycin
Hide Arm/Group Description:

250 cc normal saline

Placebo: 250 cc normal saline

Azithromycin: 500 mg in 250 cc normal saline 1 time dose
Overall Number of Participants Analyzed 992 1018
Measure Type: Count of Participants
Unit of Measure: Participants
119
  12.0%
62
   6.1%
2.Other Pre-specified Outcome
Title Neonatal Morbidities (Listed Below)
Hide Description 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
Time Frame Up to 3 months after birth
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo and Standard of Care Azithromycin and Standard of Care
Hide Arm/Group Description:
Placebo: 250 cc normal saline and standard of care (cefazolin or clindamycin)
Azithromycin: 500 mg in 250 cc normal saline 1 time dose and Standard of Care (cefazolin or clindamycin
Overall Number of Participants Analyzed 992 1018
Measure Type: Count of Participants
Unit of Measure: Participants
135
  13.6%
146
  14.3%
3.Other Pre-specified Outcome
Title Neonatal Intensive Care Unit (NICU) Admission
Hide Description 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.
Time Frame Up to 3 months after birth
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo and Standard of Care Azithromycin and Standard of Care
Hide Arm/Group Description:

250 cc normal saline

Placebo: 250 cc normal saline and Standard of care (cefazolin or clindamycin)

Azithromycin: 500 mg in 250 cc normal saline 1 time dose and Standard of care (cefazolin or clindamycin)
Overall Number of Participants Analyzed 992 1018
Measure Type: Count of Participants
Unit of Measure: Participants
169
  17.0%
171
  16.8%
4.Other Pre-specified Outcome
Title Neonatal Readmission
Hide Description [Not Specified]
Time Frame Up to 3 months after birth
Hide Outcome Measure Data
Hide Analysis Population Description
Hospitalization after discharge
Arm/Group Title Placebo With Standard Prophylaxis Azithromycin (Zithromax) With Standard Prophylaxis
Hide Arm/Group Description:
Placebo: 250 cc normal saline Standard Prophylaxis: standard cephalosporin prophylaxis
Azithromycin: 500 mg in 250 cc normal saline 1 time dose Standard Prophylaxis: standard cephalosporin prophylaxis
Overall Number of Participants Analyzed 992 1018
Measure Type: Count of Participants
Unit of Measure: Participants
43
   4.3%
39
   3.8%
5.Other Pre-specified Outcome
Title Maternal Fever
Hide Description [Not Specified]
Time Frame Up to 6 weeks after delivery
Hide Outcome Measure Data
Hide Analysis Population Description
Postpartum Fever
Arm/Group Title Placebo With Standard Prophylaxis Azithromycin (Zithromax) With Standard Prophylaxis
Hide Arm/Group Description:
Placebo: 250 cc normal saline Standard Prophylaxis: standard cephalosporin prophylaxis
Azithromycin: 500 mg in 250 cc normal saline 1 time dose Standard Prophylaxis: standard cephalosporin prophylaxis
Overall Number of Participants Analyzed 992 1018
Measure Type: Count of Participants
Unit of Measure: Participants
81
   8.2%
51
   5.0%
6.Other Pre-specified Outcome
Title Maternal Postpartum Readmission or Unscheduled Visit
Hide Description Maternal postpartum unscheduled visit or readmission to the hospital
Time Frame Up to 6 weeks after delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo and Standard of Care Azithromycin and Standard of Care
Hide Arm/Group Description:
Placebo: 250 cc normal saline Standard of care (cefazolin or clindamycin)
Azithromycin: 500 mg in 250 cc normal saline 1 time dose Standard of care (cefazolin or clindamycin)
Overall Number of Participants Analyzed 992 1018
Measure Type: Count of Participants
Unit of Measure: Participants
123
  12.4%
83
   8.2%
7.Other Pre-specified Outcome
Title Maternal Postpartum Antibiotic Use
Hide Description Maternal postpartum use of antibiotics
Time Frame Up to 6 weeks after delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo and Standard of Care Azithromycin and Standard of Care
Hide Arm/Group Description:
Placebo: 250 cc normal saline and Standard of care (cefazolin or clindamycin)
Azithromycin: 500 mg in 250 cc normal saline 1 time dose and Standard of care (cefazolin or clindamycin)
Overall Number of Participants Analyzed 992 1018
Measure Type: Count of Participants
Unit of Measure: Participants
166
  16.7%
126
  12.4%
8.Other Pre-specified Outcome
Title Maternal Serious Adverse Events
Hide Description All maternal serious adverse events
Time Frame Up to 6 weeks after delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo and Standard of Care Azithromycin and Standard of Care
Hide Arm/Group Description:
Placebo: 250 cc normal saline and Standard of care (cefazolin or clindamycin)
Azithromycin: 500 mg in 250 cc normal saline 1 time dose and Standard of care (cefazolin or clindamycin)
Overall Number of Participants Analyzed 992 1018
Measure Type: Count of Participants
Unit of Measure: Participants
29
   2.9%
15
   1.5%
9.Other Pre-specified Outcome
Title Neonatal Serious Adverse Events
Hide Description Composite for all neonatal serious adverse events
Time Frame Up to 3 months after birth
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo and Standard of Care Azithromycin and Standard of Care
Hide Arm/Group Description:
Placebo: 250 cc normal saline and Standard of care (cefazolin or clindamycin)
Azithromycin: 500 mg in 250 cc normal saline 1 time dose and Standard of care (cefazolin or clindamycin)
Overall Number of Participants Analyzed 992 1018
Measure Type: Count of Participants
Unit of Measure: Participants
5
   0.5%
7
   0.7%
10.Other Pre-specified Outcome
Title Infant Pyloric Stenosis
Hide Description Any diagnosis of pyloric stenosis based on clinical presentation and radiological and/or surgical confirmation
Time Frame up to 3 months after birth
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo and Standard of Care Azithromycin and Standard of Care
Hide Arm/Group Description:
Placebo: 250 cc normal saline and Standard of care (cefazolin or clindamycin)
Azithromycin: 500 mg in 250 cc normal saline 1 time dose and Standard of care (cefazolin or clindamycin)
Overall Number of Participants Analyzed 992 1018
Measure Type: Count of Participants
Unit of Measure: Participants
1
   0.1%
2
   0.2%
Time Frame Up to 6 weeks after delivery
Adverse Event Reporting Description Maternal serious adverse events (maternal safety composite outcome) included death, suspected allergic reactions (including anaphylaxis or generalized skin rash), any serious adverse event leading to the discontinuation of a study medication or suspected to be due to the medication, and any other reported serious adverse complication, including pulmonary embolism, admission to an intensive care unit (ICU), and cardiac events.
 
Arm/Group Title Placebo and Standard of Care Azithromycin and Standard of Care
Hide Arm/Group Description Placebo: 250 cc normal saline and Standard of care (cefazolin or clindamycin) Azithromycin: 500 mg in 250 cc normal saline and Standard of care (cefazolin or clindamycin)
All-Cause Mortality
Placebo and Standard of Care Azithromycin and Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/992 (0.00%)      0/1018 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo and Standard of Care Azithromycin and Standard of Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   29/992 (2.92%)      15/1018 (1.47%)    
Immune system disorders     
Severe allergic reaction  [1]  29/992 (2.92%)  29 15/1018 (1.47%)  15
Indicates events were collected by systematic assessment
[1]
Allergy
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo and Standard of Care Azithromycin and Standard of Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/992 (1.41%)      9/1018 (0.88%)    
General disorders     
ICU admission   14/992 (1.41%)  14 9/1018 (0.88%)  9
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Alan Tita, MD
Organization: University of Alabama at Birmingham, Maternal & Fetal Medicine
Phone: 205-934-9616
EMail: atita@uab.edu
Layout table for additonal information
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