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临床试验/NCT02491151
NCT02491151已完成不适用

Fluconazole Exposure in Critically Ill Patients and the Value of Therapeutic Drug Monitoring

University Medical Center Groningen1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Plasma concentrations of fluconazole in critically ill patients

研究概览

简要总结

Fluconazole is the first-line agent in the treatment of invasive candidiasis. Studies showed inappropriate drug exposure causes high mortality in critically ill patients. Under-dosing and ineffective fluconazole trough serum concentrations were found in a recent retrospective study. Variability in fluconazole exposure can be easily measured with therapeutic drug monitoring. For patient groups who are at risk for drug underexposure, therapeutic drug monitoring can be valuable regards decreasing mortality.

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
All
接受健康志愿者

入选标准

  • Patient is 18 years or older.
  • Treatment with fluconazole.
  • Written informed consent obtained from patient.
  • Written informed consent obtained from representative of patient.

排除标准

  • Blood sampling not possible

结局指标

主要结局

Plasma concentrations of fluconazole in critically ill patients

时间窗: Up to one month

Plasma concentrations of fluconazole will be determined using a validated method involving LC-MS/MS

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jan-Willem C Alffenaar

Associate Professor of Medicine

University Medical Center Groningen

研究点 (1)

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