The Pharmacokinetics of Azithromycin Prophylaxis for Cesarean Delivery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of Patients in Each Group That Attain an Adequate Azithromycin Concentration
研究概览
简要总结
PKAZ is a single institution study designed to evaluate the optimal dosing parameters for azithromycin for pre-surgical cesarean prophylaxis.
Hypothesis: Pre-operative administration of azithromycin results in maternal and neonatal tissue concentrations that adequately treat microbes commonly involved in post-cesarean infections.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women 19 years and older
- •Term (37 weeks and greater)
- •Singleton gestation
- •Scheduled cesarean section
- •Non-laboring
- •Intact membranes
排除标准
- •< 19 years of age
- •Preterm (< 37 weeks)
- •Multifetal gestation
- •Laboring or ruptured membranes
- •Known fetal anomaly
- •Oligo- or polyhydramnios
- •Macrolide allergy
- •Macrolide exposure within 2 weeks
- •Medical co-morbidities
- •Hepatic or renal impairment
- •Taking medications that prolong the QT interval
- •Currently taking nelfinavir, efavirenz, or flucanozole
- •Structural heart defects or arrythmia
研究组 & 干预措施
15 minutes
500 mg of intravenous azithromycin will be administered 15 minutes prior to incision.
干预措施: Azithromycin (Drug)
30 minutes
500 mg of intravenous azithromycin will be administered 30 minutes prior to incision.
干预措施: Azithromycin (Drug)
60 minutes
500 mg of intravenous azithromycin will be administered 60 minutes prior to incision.
干预措施: Azithromycin (Drug)
结局指标
主要结局
Number of Patients in Each Group That Attain an Adequate Azithromycin Concentration
时间窗: 48 hours after delivery
The primary outcome of this study will be the number of patients in each group that attain an azithromycin concentration in the various maternal and fetal tissues at least equivalent to the MIC 90 for common organisms involved in post-cesarean infections.
次要结局
未报告次要终点
研究者
Amelia Sutton, MD, PhD
Fellow/Instructor, Maternal Fetal Medicine
University of Alabama at Birmingham