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临床试验/NCT02609646
NCT02609646已完成不适用

Antibiotic Pharmacokinetics in Critically Ill Patients

Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva11 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2016年1月最近更新:
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
发起方
入组人数
1,500
试验地点
11
主要终点
Drug plasma concentration (time-dependent antibiotics)

研究概览

简要总结

The purpose of this study is to investigate the pharmacokinetic properties in critically ill patients of a few of the most used antimicrobial drugs (amikacin, linezolid, meropenem, piperacillin/tazobactam, vancomycin). The primary objective is the identification of the clinical parameters affecting the kinetics of these drugs and the study of the contribution of extracorporeal depuration techniques to the elimination of these molecules. The secondary objective is to describe and compare the therapeutic therapies adopted in the Intensive Care Units participating in the project.

For each molecule, the study will involve 300 patients admitted to Intensive Care Units. For each patient five blood samples will be collected on average, in order to measure drug plasma concentrations. Patient clinical conditions will be collected through an electronic clinical record. Finally, on the basis of those data, pharmacokinetic models will be developed to describe the evolution in time of drug plasma concentrations.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • patients undergoing antibiotic therapy with amikacin, linezolid, meropenem, piperacillin/tazobactam, or vancomycin.
  • patients whose antibiotic therapy started during the stay in ICU or less than 24h before admission to ICU.
  • patients with anticipated length of stay in ICU of at least 24h.
  • patients with already-placed catheter

排除标准

  • patients undergoing antibiotic prophylaxis
  • lack of informed consent

研究组 & 干预措施

linezolid

patients treated with linezolid

干预措施: Linezolid (Drug)

meropenem

patients treated with meropenem

干预措施: Meropenem (Drug)

piperacillin/tazobactam

patients treated with piperacillin/tazobactam

干预措施: Piperacillin-tazobactam combination product (Drug)

vancomycin

patients treated with vancomycin

干预措施: Vancomycin (Drug)

结局指标

主要结局

Drug plasma concentration (time-dependent antibiotics)

时间窗: 30 min after first dose; 1 day after first dose; 2 day after first dose; 2 measures between the 3rd and the 8th day of treatment

Drug plasma concentration (concentration-dependent antibiotics)

时间窗: 30 min after first dose; immediately before second dose; peak and trough of the same dose in the 2nd day of therapy; peak and trough of the same dose between the 3rd and the 5th day of therapy

次要结局

未报告次要终点

研究者

发起方
Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva
申办方类型
Other
责任方
Sponsor

研究点 (11)

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