Pharmacokinetics of Micafungin in Critically Ill Patients With Invasive Candidiasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Correlation of pharmacokinetic parameters/plasma concentrations of micafungin with disease severity.
研究概览
简要总结
A study of micafungin in ICU versus non-ICU patients showed a significantly lower treatment success in ICU patients compared with non-ICU patients. It is known that in critically ill patients, alterations in function of various organs and body systems can influence the pharmacokinetics and hence the plasma concentration of a drug. The pharmacokinetic parameters of micafungin in critically ill patients are most likely different, but this has not been specifically studied.
The pharmacokinetic parameters of micafungin in critically ill patients will be established and plasma concentrations of micafungin will be correlated with disease severity.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treatment with micafungin.
- •Admission to an ICU.
- •Age ≥ 18 years.
- •Invasive candidiasis.
排除标准
- •Blood sampling not possible.
结局指标
主要结局
Correlation of pharmacokinetic parameters/plasma concentrations of micafungin with disease severity.
时间窗: 4 days
Correlation of the level of micafungin concentration with disease severity scores. Correlation of pharmacokinetic parameters (clearance, half-life) of micafungin with disease severity scores.
次要结局
- Correlation of the plasma concentration of micafungin with inflammation parameters.(4 days)
- Time (in days) to culture conversion.(max 28 days)
- Correlation of the plasma concentration of micafungin with response to treatment.(max 28 days)
- Pharmacokinetic parameters of micafungin in ICU patients.(4 days)
- Area under the concentration-time curve (AUC)/minimal inhibitory concentration (MIC) ratio.(max 28 days)
- Composing a pharmacokinetic model of micafungin in critically ill patients.(max 28 days)
- Highest observed plasma concentration (Cmax)/minimal inhibitory concentration (MIC) ratio.(28 days)
研究者
Jan-Willem C Alffenaar
PharmD, PhD
University Medical Center Groningen