Clindamycin pharmacokinetics during obstetric or fetal surgery
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- UZ Leuven
- 试验地点
- 1
- 主要终点
- A population pharmacokinetic analysis approach will be performed, comparing the data on PK already reported in adults or other pregnant women and the newly collected data during pregnancy. The quality of fit of the pharmacokinetic model to the data will be sought by NONMEM's objective function and by visual examination of plots of observed vs predicted concentrations. Clindamycin concentrations in maternal plasma and amniotic fluid will be measured at the different sample collection timepoints.
研究概览
简要总结
The primary aim is to describe the pharmacokinetics of clindamycin and its metabolites during pregnancy, in the relevant compartments (maternal plasma, amniotic fluid) during and following obstetric or fetal surgery by performing a population pharmacokinetics analysis approach.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures,
- •Singleton and twin pregnancy that fulfill criteria for fetal and obstetric interventions in the second and third trimester of pregnancy,
- •Admitted and hospitalized at the obstetrics surgery ward,
- •Monochorionic twin pregnancy identified to have twin-twin transfusion syndrome (TTTS) or selective fetal growth restriction (sFGR) requiring fetoscopic laser surgery (FLS),
- •Singleton pregnancy undergoing fetal interventions or surgery for example for Congenital Diaphragmatic Hernia (CDH) or Myelomeningocele (MMC),
- •Planned (prescribed) IV dosing of clindamycin as prophylaxis before surgery.
排除标准
- •Participant has pre-existing type I diabetes,
- •Any disorder, which in the Investigator's opinion might jeopardize the participant's safety or compliance with the protocol,
- •Any prior or concomitant treatment(s) that might jeopardize the participant's safety or that would compromise the integrity of the Trial,
- •Participation in an interventional Trial with an investigational medicinal product (IMP) or device,
- •Contraindication for clindamycin (non-limitative: hypersensitivity,...),
- •Treatment with CYP450 inductor within 14 days before clindamycin initiation (e.g., carbamazepine, efavirenz).
结局指标
主要结局
A population pharmacokinetic analysis approach will be performed, comparing the data on PK already reported in adults or other pregnant women and the newly collected data during pregnancy. The quality of fit of the pharmacokinetic model to the data will be sought by NONMEM's objective function and by visual examination of plots of observed vs predicted concentrations. Clindamycin concentrations in maternal plasma and amniotic fluid will be measured at the different sample collection timepoints.
A population pharmacokinetic analysis approach will be performed, comparing the data on PK already reported in adults or other pregnant women and the newly collected data during pregnancy. The quality of fit of the pharmacokinetic model to the data will be sought by NONMEM's objective function and by visual examination of plots of observed vs predicted concentrations. Clindamycin concentrations in maternal plasma and amniotic fluid will be measured at the different sample collection timepoints.
次要结局
- Pharmacokinetic analysis, including the covariates of interest or relevant clinical characteristics i.e., body weight, length, age, body surface area (BSA), gestational age, type of delivery, intercurrent co-morbidity (e.g., renal and hepatic dysfunction, hypothermia, hypothyroidism), other parenteral or other co-medications.
研究者
Sofia Mastrodima-Polychroniou
Scientific
UZ Leuven