跳至主要内容
临床试验/NCT04502771
NCT04502771已完成不适用

Therapeutic Drug Monitoring of Antifungals in Patients From Intensive Care Units: a Retrospective Study

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年1月1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
200
试验地点
1
主要终点
Antifungal blood concentration of patients admitted in intensive care units

研究概览

简要总结

Antifungals under- and over-dosing are frequently deplored in patients treated with antifungals and receiving recommended doses, mostly in critically-ill patients. This situation is well-described for antifungals from the azoles class mostly in patients with liver dysfunction or having concomitant drugs that may interact with azoles. This situation is less-described using echinocandins, although recent studies reported caspofungin underdosing for critically-ill patients. Considering that antifungals under-dosing was demonstrated to be associated with an increase in mortality, it is of utmost importance to analyse the relevance of therapeutic drug monitoring (TDM) for patients admitted in intensive care units (ICU). This will help to identify which patients are the more prone to antifungal under or over-dosing. Indeed, antifungals under-dosing may favour the development of clinical resistance to antifungals and increase mortality, whereas over-dosing may result in adverse events that may lead to treatment discontinuation.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients who received antifungals including fluconazole, voriconazole, posaconazole, or caspofungin, during their ICU stay and had a Therapeutic Drug Monitoring (TDM)

排除标准

  • Patients without antifungal treatment
  • Patients who received an antifungal combination
  • Pediatric patients
  • Patients who were not admitted in ICU
  • Patients who did not have a TDM

研究组 & 干预措施

Antifungal treatment

Patients receiving antifungal treatment during their stay in Intensive Care Unit

干预措施: Antifungal treatment (Drug)

结局指标

主要结局

Antifungal blood concentration of patients admitted in intensive care units

时间窗: Day 5 after antifungal initiation

次要结局

  • Adverse event(Day 30 after antifungal initiation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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