Pharmacokinetics and Optimal Dosage of Caspofungin in Critically Ill Patients With Suspected Invasive Candidiasis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The optimal dosage of caspofungin in relation to adequate exposure (measured as AUC) in critically ill patients.
研究概览
简要总结
Intensive care unit (ICU) patients are especially at risk for invasive candidiasis due to the presence of risk factors. 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. A study of caspofungin in ICU patients has found a high inter- and intra-individual variability in caspofungin concentration. Factors that caused subtherapeutic caspofungin plasma concentrations were body weight > 75 kg and hypoalbuminemia. Furthermore, an efficacy study showed a lower response rate for caspofungin among patients with a higher disease severity score.
As a result of the altered pharmacokinetics, under- or over-exposure of caspofungin can occur in critically ill patients and an adjusted dosage might be necessary in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 caspofungin.
- •Admission to an ICU.
- •Age ≥ 18 years.
- •Suspected invasive candidiasis, established by the physician.
排除标准
- •Blood sampling by central venous catheter or peripheral cannula not possible.
研究组 & 干预措施
Caspofungin
1 arm, dose adjustment of caspofungin when exposure is inadequate
干预措施: Caspofungin (Drug)
结局指标
主要结局
The optimal dosage of caspofungin in relation to adequate exposure (measured as AUC) in critically ill patients.
时间窗: 7 days
次要结局
- Pharmacokinetic parameters of caspofungin in critically ill patients.(3 days)
- Correlation of pharmacokinetic parameters and the plasma concentration of caspofungin with disease severity scores.(3 days)
- Correlation of the plasma concentration of caspofungin with candida eradication.(28 days)
- Correlation of the plasma concentration of caspofungin with inflammation parameters.(3 days)
- AUC/MIC ratio and highest observed plasma concentration (Cmax)/MIC ratio.(7 days)
- Constructing a pharmacokinetic model of caspofungin in critically ill patients.(28 days)
- Drug-related adverse events of caspofungin.(28 days)
研究者
JWC Alffenaar
PharmD, PhD
University Medical Center Groningen