Compare Effectiveness of Azithromycin Prophylaxis to Single Agent to Prevent Post Cesarean Infection

Condition(s) targeted: Endometritis

Intervention: Azithromycin (Drug); Placebo (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Alan Tita

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

Overall contact:
Alan TN Tita, PhD, MD, Phone: 205-934-9616, Email: alan.tita@obgyn.uab.edu

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 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.

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 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

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

Alan TN Tita, PhD, MD, Phone: 205-934-9616, Email: alan.tita@obgyn.uab.edu

University of Alabama at Birmingham, Birmingham, Alabama 35233, United States; Recruiting
Alan TN Tita, PhD, MD, Principal Investigator

University of North Carolina, Chapel Hill, North Carolina 27599-7516, United States; Recruiting
Kim Boggess, MD, Principal Investigator

University of Texas Medical Branch, Galveston, Texas 77555-0587, United States; Recruiting
George Saade, MD, Principal Investigator

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. 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.

Starting date: May 2011
Last updated: September 6, 2011