跳至主要内容
临床试验/EUCTR2010-023683-41-IT
EUCTR2010-023683-41-IT进行中(未招募)不适用

Pk/Pd aspects of linezolid in critically ill patients with late onset Ventilator-Associated Pneumonia. Intermittent versus Continuous Infusion Introduction - ND

POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI0 个研究点开始时间: 2010年12月24日最近更新:
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • all critically ill adult patients who are mechanically ventilated in Intensive Care Unit (ICU) for more than 96 hours developing VAP (CPIS value=6 or new and persistent infiltrate on chest radiography without another obvious cause associated with any two of the following conditions: purulent tracheal secretions, temperature of 38.?C or higher, leukocyte count higher than 11000/µL or lower than 3500/µL, increasing oxygen requirements, recent finding of pathogenic bacteria from respiratory secretions). Anuric patients can be enrolled if they are yet receiving CVVHDF.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • are < 18 years
  • are pregnant
  • are allergic to linezolid
  • have creatinine clereance ClCR <40 ml/min (calculated according to Cocrockft-Gault formula), with the exception of anuric ones undergoing CVVHDF
  • present thrombocytopenia (platelets count<80000/mmc)
  • have severe hepatic failure (Child-Pugh C)
  • have little chance of survival as defined by Symplified Acute Physiology Score (SAPS II)
  • are treated with other drugs that can potentially interfere with linezolid (i.e. erythromycin, serotonin modulators).
  • Absence of infromed consent

研究者

发起方
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

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