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
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