Azithromycin Pharmacokinetics and Pharmacodynamics in Pregnancy and Preterm Birth Prevention: Optimizing Dosing to Improve Maternal and Neonatal Outcomes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Azithromycin trough in amniotic fluid
研究概览
简要总结
This is a pilot randomized controlled trial to assess the pharmacokinetics and pharmacodynamics of azithromycin in pregnant singletons admitted with preterm premature rupture of membranes (PPROM) at 24 0/7- 33 0/7. Participants will be randomized 1:1 to either 1000mg azithromycin orally once or 500mg azithromycin orally daily for seven days in addition to standard care.
详细描述
This is a pilot randomized controlled trial to assess the pharmacokinetics and pharmacodynamics of azithromycin in pregnant singletons admitted with preterm premature rupture of membranes (PPROM) at 24 0/7- 33 0/7. Participants will be randomized 1:1 to either 1000mg azithromycin orally once or 500mg azithromycin orally daily for seven days in addition to standard care. During the course of eight days participants will have serial collection of amniotic fluid, maternal serum; and at delivery, of placenta, membrane, and cord blood. After delivery, neonatal respiratory samples will be collected as well.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Singleton gestation 24 0/7 -33 0/7 weeks'
- •Diagnosed with preterm premature rupture of membranes:
- •History consistent with ruptured membranes (ie leaking, gush of fluid)
- •Sterile speculum exam with pooling
- •Fluid positive for ferning and/or nitrazine
- •With or without confirmatory test such as Amnisure
排除标准
- •• Contraindication to azithromycin
- •Active labor, abruption, chorioamnionitis at enrollment
- •Other contraindication to expectant management of PPROM at enrollment
研究组 & 干预措施
Azithromycin 500mg
500mg azithromycin PO daily for seven days
干预措施: Azithromycin 500 mg (Drug)
Azithromycin 1000mg
1000mg azithromycin PO once at admission
干预措施: Azithromycin Oral Product (Drug)
结局指标
主要结局
Azithromycin trough in amniotic fluid
时间窗: 8 days
Primary outcome is the mean difference in azithromycin trough (Cmin) in amniotic fluid between the two dosing regimens using nonparametric test
次要结局
- Intra-amniotic infection(3 months (delivery))
- Histologic chorioamnionitis(3 months (delivery))
- IL-6 in amniotic fluid(8 days)
- IL-8 in cord blood(3 months (delivery))
- Respiratory ureaplasma colonization in neonate(3 months)
- Trend in amniotic fluid cytokines(8 days)
- Latency to delivery(3 months)
- ureaplasma colonization of membranes(3 months)