Azithromycin Prophylaxis for Prelabor Cesarean Delivery Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 8,000
- 试验地点
- 14
- 主要终点
- Maternal infection composite
研究概览
简要总结
This is a phase-III multi-center double-blind randomized controlled trial of 8,000 individuals undergoing a scheduled or prelabor cesarean delivery who are randomized to either adjunctive azithromycin prophylaxis or to placebo. Both groups also will receive standard of care preoperative antibiotics (excluding azithromycin). The primary endpoint is a maternal infection composite defined as any one of the following up to 6 weeks postpartum: endometritis, wound infection, abscess, septic thrombosis, sepsis, pneumonia, pyelonephritis and breast infection.
详细描述
This is a phase-III multi-center double-blind randomized controlled trial of 8,000 individuals undergoing a scheduled or prelabor cesarean delivery who are randomized to either azithromycin prophylaxis or to placebo. All participants will receive standard of care preoperative antibiotics. The primary objective is to evaluate in patients undergoing scheduled/prelabor cesarean if pre-incision adjunctive azithromycin prophylaxis reduces the risk of post-cesarean infections compared with placebo. Secondary objectives include 1) to assess the perinatal and maternal safety of pre-incision adjunctive azithromycin, 2) to evaluate whether adjunctive azithromycin prophylaxis reduces maternal and neonatal resource use outcomes compared with placebo, and 3) to evaluate whether adjunctive azithromycin influences maternal and neonatal infection with resistant organisms compared with placebo.
Individuals will be randomized prior to the start of the cesarean to either 500mg of intravenous azithromycin or to placebo (normal saline). Maternal blood and cord blood will be collected on a subset of the population. Research staff will abstract maternal and neonatal outcomes following delivery and discharge from the hospital. A single maternal follow-up study visit at 6 weeks (4-8 weeks) postpartum will be scheduled to ascertain maternal and neonatal outcomes.
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)
盲法说明
The study medication will be prepared by the center research pharmacies from a list provided by the independent data coordinating center, with the active and placebo medication having identical appearance. No other individuals, including the participant or any other clinical or research staff will be informed of the study assignment.
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •≥ 23 weeks' gestation (ACOG dating criteria)
- •Scheduled or prelabor cesarean delivery
- •Singleton or twin gestation
排除标准
- •Allergy or contraindication to azithromycin or macrolide antibiotics, including those with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin
- •Chorioamnionitis
- •Bacterial infection (e.g., pyelonephritis) requiring ongoing antibiotic treatment after delivery
- •Premature rupture of membranes (PROM) or labor (i.e., contractions with ongoing cervical change)
- •Fetal demise or known major congenital anomaly
- •Azithromycin treatment within 7 days
- •Planned use of antimicrobial prophylaxis after delivery for any reason
- •Known structural heart disease or active cardiomyopathy (current ejection fraction<40%)
- •Known arrhythmia with QT prolongation or taking scheduled medications known to prolong the QT interval such that it would preclude the use of azithromycin
- •Refusal or unable to obtain consent (e.g., language barrier)
- •Participating in another intervention study that influences the primary outcome in this study
- •Participation in this trial in a previous pregnancy. Patients who were screened in a previous pregnancy, but not randomized, do not have to be excluded.
研究组 & 干预措施
Azithromycin prophylaxis and standard of care preoperative antibiotics
500mg of intravenous azithromycin administered up to 1 hour prior to cesarean incision (or as soon as feasible after incision) and infused over one hour per FDA infusion recommendations for azithromycin. Additionally patients will received standard of care preoperative antibiotics (excluding azithromycin) prior to incision.
干预措施: Standard of Care Preoperative antibiotics (Drug)
Placebo and standard of care preoperative antibiotics
Normal saline administered up to 1 hour prior to cesarean incision (or as soon as feasible after incision) and infused over one hour in addition to standard of care preoperative antibiotics (excluding azithromycin) prior to incision.
干预措施: Placebo (Drug)
Placebo and standard of care preoperative antibiotics
Normal saline administered up to 1 hour prior to cesarean incision (or as soon as feasible after incision) and infused over one hour in addition to standard of care preoperative antibiotics (excluding azithromycin) prior to incision.
干预措施: Standard of Care Preoperative antibiotics (Drug)
Azithromycin prophylaxis and standard of care preoperative antibiotics
500mg of intravenous azithromycin administered up to 1 hour prior to cesarean incision (or as soon as feasible after incision) and infused over one hour per FDA infusion recommendations for azithromycin. Additionally patients will received standard of care preoperative antibiotics (excluding azithromycin) prior to incision.
干预措施: Azithromycin Injection (Drug)
结局指标
主要结局
Maternal infection composite
时间窗: Delivery up to 6 weeks postpartum (a period of up to 6 weeks)
a maternal infection composite defined as any one of the following: endometritis, wound infection, abdominal or pelvic abscess, septic pelvic thrombosis, sepsis, pneumonia, pyelonephritis and breast infection
次要结局
- Non-infections wound complications(Delivery up to 6 weeks postpartum (a period of up to 6 weeks))
- Perinatal composite outcome(hospital discharge, 6 weeks of birth, or death (whichever occurs first))
- Number of neonates with Allergic Reaction(birth through hospital discharge, or 7 days from birth, whichever is earliest)
- Number of Neonates with Gastrointestinal Symptoms(birth through hospital discharge, or 7 days from birth, whichever is earliest)
- Number of Maternal Deaths(From randomization through 6 weeks postpartum (a period of up to 6 weeks))
- Maternal Resource Composite(From hospital discharge following delivery through 6 weeks postpartum (a period of up to 6 weeks))
- Neonatal Resource Composite(From hospital discharge following delivery through 6 weeks postpartum (a period of up to 6 weeks))
- Maternal Hospital Length of Stay(Hospital admission to hospital discharge (up to 42 days))
- Rate of Neonatal ICU Admission(Delivery to hospital discharge (up to 120 days))
- Number of Participants with Maternal Resistant Infection(Randomization through 6 weeks postpartum (a period of up to 6 weeks))
- Number of Neonates with Neonatal Resistant Infection(From birth up to 6 weeks of age)