Pharmacokinetics and Pharmacodynamics of Caspofungin in Children Severe Infection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter
研究概览
简要总结
Caspofungin is an anti-fungal drug mainly metabolized by the liver. The pathophysiological status of children with severe infection will affect the metabolism of caspofungin in the body especially in the case of liver dysfunction. There is little metabolism of caspofungin through the kidney and continuous renal replacement therapy and renal function have little influence on the pharmacokinetics of caspofungin. The study aim to investigate PK/PD of caspofungin in children with specific pathophysiological conditions, such as liver insufficiency, hypoproteinemia, ECMO treatment, or sepsis.
详细描述
The current international recommended dose of caspofungin is 70 mg per square metre for load for children who is older than three months of age, followed by 50 mg per square metre for maintenance. For newborns and infants younger than 3 months of age，25 mg per square metre is also recommended.
Whether such a recommended dose can achieve an ideal PK/PD target in children with liver insufficiency, hypoproteinemia, ECMO treatment, or severe infection is still lacking in sufficient clinical data.
The objective of this study is to investigate PK/PD of caspofungin in children with specific pathophysiological conditions, such as liver insufficiency, hypoproteinemia, ECMO treatment, or sepsis.
Blood sampling time points of caspofungin are listed as follow:
Before administration (0 min); 1 h, 2 h, 4 h, 8 h , 12 h and 24 h after administration.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children receiving caspofungin in pediatric intensive care unit
排除标准
- •No Informed Consent signed Participate in other clinical trials
研究组 & 干预措施
Treatment group
Children treated with caspofungin in the pediatric intensive care unit
干预措施: Caspofungin (Drug)
结局指标
主要结局
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter
时间窗: Day 1-5
Time to reach the maximum plasma concentration (Tmax) after administrations of a single dose and multiple doses of the study drug
次要结局
- Terminal Phase Elimination Half-life (T1/2) Pharmacokinetic Parameter(Day1-5)
- AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Pharmacokinetic Parameter(Day1-5)
- AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Pharmacokinetic Parameter(Day1-5)
- Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter(Day 1-5)