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Study of Effectiveness and Safety of Azithromycin-based Extended-spectrum Prophylaxis to Prevent Post Cesarean Infection

Information source: University of Alabama at Birmingham
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Endometritis; Wound Infection; Abscess; Surgical Site Infection

Intervention: Azithromycin (Drug); Placebo (Drug)

Phase: N/A

Status: Completed

Sponsored by: Alan Tita

Official(s) and/or principal investigator(s):
Alan TN Tita, MD, PhD, Principal Investigator, Affiliation: University of Alabama at Birmingham

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.

Clinical Details

Official title: Cesarean Section Optimal Antibiotic Prophylaxis Trial

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Composite of endometritis and/or wound infection and/or other post-cesarean infections (occurring within 4-6 weeks of delivery)

Secondary outcome: • Individual post-cesarean infections: Endometritis, wound infection (including necrotizing fascitis), other infections including abscess, septic thrombosis, pneumonia, pyelonephritis and breast infection

Eligibility

Minimum age: 14 Years. Maximum age: N/A. Gender(s): Female.

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

Locations and Contacts

University of Alabama at Birmingham, Birmingham, Alabama 35233, United States

Ochsner Clinic Foundation, New Orleans, Louisiana 70121, United States

University of Mississippi Medical Center, Jackson, Mississippi 39216, United States

Columbia University, New York, New York 10032, United States

Mission Hospital, Ashville, North Carolina 28801, United States

University of North Carolina, Chapel Hill, North Carolina 27599-7516, United States

University of Texas Medical Branch, Galveston, Texas 77555-0587, United States

University of Texas Health Science Center at Houston, Houston, Texas 77225, United States

University of Utah, Salt Lake City, Utah 84132, United States

Additional Information

Related publications:

Tita AT, Rouse DJ, Blackwell S, Saade GR, Spong CY, Andrews WW. Emerging concepts in antibiotic prophylaxis for cesarean delivery: a systematic review. Obstet Gynecol. 2009 Mar;113(3):675-82. doi: 10.1097/AOG.0b013e318197c3b6. Review.

Andrews WW, Hauth JC, Cliver SP, Savage K, Goldenberg RL. Randomized clinical trial of extended spectrum antibiotic prophylaxis with coverage for Ureaplasma urealyticum to reduce post-cesarean delivery endometritis. Obstet Gynecol. 2003 Jun;101(6):1183-9.

Tita AT, Hauth JC, Grimes A, Owen J, Stamm AM, Andrews WW. Decreasing incidence of postcesarean endometritis with extended-spectrum antibiotic prophylaxis. Obstet Gynecol. 2008 Jan;111(1):51-6. doi: 10.1097/01.AOG.0000295868.43851.39.

Starting date: May 2011
Last updated: May 21, 2015

Page last updated: August 20, 2015

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