跳至主要内容
临床试验/EUCTR2011-002603-15-ES
EUCTR2011-002603-15-ES进行中(未招募)不适用

Early treatment with ganciclovir of active infection by cytomegalovirus (CMV) in critically ill patients on mechanical ventilation with severe sepsis or septic shock

FUNDACION INVESTIGACION HOSPITAL CLINICO DE VALENCIA-INSTITUTO DE INVESTIGACION SANITARIA INCLIVA0 个研究点开始时间: 2011年9月28日最近更新:
适应症
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

  • ? Signing the informed consent (patient or family)
  • ? Age equal or greater than 18 years
  • ? Positive serology for CMV (IgG and/or IgM) at the time of admission
  • ? active CMV infection during their ICU stay (> 10 CMV DNA copies/ml of tracheal aspirate and/or peripheral blood).
  • ? Severe sepsis or septic shock (it will follow the definitions of the consensus conference) requiring mechanical ventilation.
  • ? Women of childbearing potential must test negative serum or urine test and use effective contraception.
  • ? Admitted to ICU
  • 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 42
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 42

排除标准

  • ? Patients who are participating in other clinical trials.
  • ? Immunosuppression known at the time of admission
  • ? Neutropenia (neutrophils <500/?l)
  • ? Thrombocytopenia (<25x10^9/L)
  • ? Liver failure: bilirubin>2 mg/dL
  • ? Patients who are pregnant or breastfeeding.
  • ? Other contraindications listed in the Summary of ganciclovir

研究者

发起方
FUNDACION INVESTIGACION HOSPITAL CLINICO DE VALENCIA-INSTITUTO DE INVESTIGACION SANITARIA INCLIVA

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