Population Pharmacokinetic of Piperacillin/Tazobactam in Maternal and Neonatal Populations With High Risk for EOS
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Clearance (L/h) of piperacillin/tazobactam
研究概览
简要总结
The purpose of this study is to describe the population pharmacokinetic characteristics of piperacillin/tazobactam after intravenous administration in pregnant women during pregnancy and delivery, and to evaluate pharmacodynamic effectiveness and safety of piperacillin/tazobactam in pregnant women whose baby are at high risk of developing early-onset sepsis after birth.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years old;
- •Pregnant women whose baby are at high risk of developing early-onset sepsis after birth have indications to use preventive or therapeutic antibiotics, and the antibiotics used are PIP/TAZO；
- •Patients and their families are fully aware of the research content and sign the informed consent form.
排除标准
- •Intolerance or serious adverse reactions to antibiotic use;
- •Patients who stopped using PIP/TAZO more than 24 hours before delivery;
- •Receiving other systemic trial drugs;
- •There are other factors that the researchers think are not suitable for inclusion
结局指标
主要结局
Clearance (L/h) of piperacillin/tazobactam
时间窗: Through study completion, an average of 20 days.
The mean population pharmacokintic parameter as well as its interindividual variability
Volume of Distribution (L) of piperacillin/tazobactam
时间窗: Through study completion, an average of 20 days.
The mean population pharmacokintic parameter as well as its interindividual variability
次要结局
- PD target attainment(Through study completion, an average of 20 days.)
- Adverse events(Through study completion, an average of 20 days.)
研究者
Wei Zhao
Head of department of clinical pharmacy and pharmacology
Shandong University