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临床试验/NCT02874157
NCT02874157Unknown不适用

Evaluation of Methods for Diagnosis of Cytomegalovirus Pneumonia in Mechanically Ventilated Patient

Assistance Publique Hopitaux De Marseille1 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2012年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
450
试验地点
1
主要终点
Number of CMV positive reactivation in ICU patient for sensitivity of quantitative PCR ( qPCR ) on LBA and CMV in whole blood compared with pp65 antigenemia.

研究概览

简要总结

Viral infections are only recently been investigated in patients on mechanical ventilation (MV) in ICU. It is especially the progress in the direct detection of these pathogens that allowed intensivists to try to assess objectively the impact of viruses in their patients. This is of course of viral infections "Community" (influenza virus, rhinovirus ...), but some viruses also occur under mechanical ventilation in immunocompetent adults. This is called viral infection "nosocomial" whose Herpesviridae are the most frequent and best studied. This replication Herpesviridae in ICU patients is usually a reactivation as primary infection. This reactivation is explained by the fact that after a few days of mechanical ventilation appears immunoparalysis, which can make the bed of bacterial or viral infection.Several studies have compared the pp65 antigenemia for quantitative PCR in immmunodéprimés patients. For example, in transplant patients (solid organs), the sensitivity of antigenemia was 91%, Quantitative PCR of 95.6% while the specificity was 57% and 81.6% respectively. No work, however, has to date compared these techniques in the intensive care patient. In a subject shortly epidemiological study, the sensitivity of the quantitative PCR performed on the LBA is 80%, when compared to antigenemia. Moreover this same study shows that half of the positive PCR on the BAL are not accompanied by a positive antigenemia, suggesting that PCR may be more sensitive than antigenemia. This exam has never been validated to date in intensive care. Finally, no work has so far evaluated the diagnostic performance of quantitative PCR performed on BAL

研究设计

研究类型
Observational
观察模型
Cohort
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

  • Patient in ICU with ventilator-associated pneumonia suspicion

排除标准

  • ICU pateint undergoing invasive ventilation for less than 48 hour

结局指标

主要结局

Number of CMV positive reactivation in ICU patient for sensitivity of quantitative PCR ( qPCR ) on LBA and CMV in whole blood compared with pp65 antigenemia.

时间窗: 1 day

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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