Cesarean Section Optimal Antibiotic Prophylaxis Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,013
- 试验地点
- 9
- 主要终点
- Participants With Endometritis and/or Wound Infection and/or Other Post-cesarean Infections (Occurring Within 6 Weeks of Delivery)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
研究组 & 干预措施
Placebo and standard of care
250 cc normal saline
干预措施: Placebo and standard of care (Drug)
Azithromycin and Standard of care
500 mg Azithromycin in 250 cc normal saline
干预措施: Azithromycin and standard of care (Drug)
结局指标
主要结局
Participants With Endometritis and/or Wound Infection and/or Other Post-cesarean Infections (Occurring Within 6 Weeks of Delivery)
时间窗: Up to 6 weeks after delivery
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.
次要结局
未报告次要终点
研究者
Alan Tita
Professor
University of Alabama at Birmingham