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临床试验/NCT02596984
NCT02596984已完成不适用

Evaluation of the Pharmacokinetics of Caspofungin in ICU Patients

Centre Hospitalier Universitaire de Saint Etienne3 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年3月16日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
3
主要终点
Caspofungin pharmacokinetic : clearance (ml.min-1)

研究概览

简要总结

Although the pharmacokinetics of Caspofungin has been studied in healthy subjects and patients, only a few studies have been performed in critically-ill patients. In these patients several factors, including sepsis, shock, increased distribution volume, hepatic dysfunction and hypoalbuminemia may result in dramatic changes in antibiotic concentrations and pharmacokinetics. Caspofungin pharmacokinetic data is scarce and are results mainly from case series or animal studies. Thus, studies performed so far show Caspofungin trough concentrations either decreased, similar to usual value in non-critically ill patients or increased. One of these studies suggested that body weight and hypoalbuminemia may be the main factors associated with Caspofungin pharmacokinetic variability. Pharmacokinetic parameters of caspofungin in pigs with hypovolemic shock suggested the peripheral volume of distribution of caspofungin and intercompartmental clearance to be higher than in healthy animals. These results are however preliminary and cannot be extrapolated suggesting further clinical studies in human to be needed.

The primary objective of this study is to assess Caspofungin trough concentrations and pharmacokinetics in critically-ill patients requiring vasopressors.

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

入选标准

  • Adult patients (age > 18 y.o)
  • Either preemptive, empirical or curative prescription of Caspofungin by one of the ICUs' attending physician
  • Requiring vasopressors
  • Admission in one of the participating ICUs.

排除标准

  • Pregnancy
  • Lack of affiliation to the National Medical Insurance
  • Previous inclusion in the study
  • Inclusion in a concomitant study that may interact with the current study

研究组 & 干预措施

caspofungin

Experimental

Caspofungin will be administered according to the international recommendation.

干预措施: Caspofungin (Drug)

结局指标

主要结局

Caspofungin pharmacokinetic : clearance (ml.min-1)

时间窗: day 2 - day 3 - day 4

Caspofungin pharmacokinetic : volume of distribution (mL)

时间窗: day 2 - day 3 - day 4

次要结局

  • Caspofungin trough concentration(day 2 - day 3 - day 4)
  • proportion of patients for whom the trough concentrations are lower than the MIC (Minimum Inhibitory Concentration) 90 of Candida ( 1mg / L)(day 2 - day 3 - day 4)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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