N/A
N=2,013
Study of Effectiveness and Safety of Azithromycin-based Extended-spectrum Prophylaxis to Prevent Post Cesarean Infection
Endometritis · Wound Infection · Abscess · Surgical Site Infection
Bottom Line
View on ClinicalTrials.gov: NCT01235546 ↗Enrolled (actual)
2,013
Serious AEs
2.2%
Results posted
Jul 2017
Primary outcome: Primary: Participants With Endometritis and/or Wound Infection and/or Other Post-cesarean Infections (Occurring Within 6 Weeks of Delivery) — 119; 62 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Azithromycin and standard of care (Drug); Placebo and standard of care (Drug)
- Age
- Pediatric, Adult, Older Adult · 14+ yrs
- Sex
- Female
- Sponsor
- Alan Tita
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With Endometritis and/or Wound Infection and/or Other Post-cesarean Infections (Occurring Within 6 Weeks of Delivery) |
119; 62 | — |
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.
Eligibility Criteria
Inclusion Criteria
-
Pregnant Women aged 14 years and over at ≥ 24 weeks' viable gestation who will undergo unscheduled/non-elective cesareans with either:
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT01235546). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.