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临床试验/DRKS00011023
DRKS00011023进行中(未招募)4 期

Therapeutic drug Monitoring (TDM) of piperacillin in patients with fever in neutropenia in the course of myelosuppressive cytostatic chemotherapy - TARGET-F

niversitätsklinikum Jena0 个研究点目标入组 38 人开始时间: 2016年9月2日最近更新:
适应症

试验速览

阶段
4 期
状态
进行中(未招募)
发起方
入组人数
38

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized controlled study
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 one(—)
性别
All

入选标准

  • Fever (defined as 1 episode >38,3°C or 2 episodes >38,0°C within 2 hours) in neutropenia (defined as WBC < 1 Gpt/l or neutrophile granulocytes <0,5Gpt/l) following myelosuppressive chemotherapy
  • imminent or ongoing therapy with Piperacillin/Tazobactam (Pip/Taz)
  • signed informed consent

排除标准

  • Age < 18 years
  • Pregnancy/Breastfeeding
  • Women at prolific age without dependable contraception
  • Patients unable to consent
  • Medical history-documented hypersensitivity toward beta-lactam antibiotics or components of the study drug formulation (Pip/Taz)
  • Treatment with Pip/Taz at daily dose >18g within the last 24 hours before randomization
  • Participation in another interventional clinical trial
  • Prior participation in the current trial (TARGET-FN)
  • Impaired liver function (Child-Pugh C)
  • Renal failure (eGFR <40ml/min)
  • Infectious condition that requires a defined different antibiotic therapy (e.g. endocarditis)
  • Life expectancy < 90 days

研究者

发起方
niversitätsklinikum Jena

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