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临床试验/NCT00452153
NCT00452153终止不适用

Evaluation of Legionella PCR Techniques for the Routine Diagnosis of Legionellosis

Centre Hospitalier Universitaire de Saint Etienne12 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2007年3月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
200
试验地点
12
主要终点
Definite or probable legionellosis

研究概览

简要总结

The validity of molecular techniques for the diagnosis of legionellosis is not known. Although PCR can detect Legionella pneumophila (responsible for 80% of legionellosis) and other Legionella species, this test is not recommended in standard guidelines to assess this diagnostic, by contrast to culture of sputum, serology and urine antigen. The aim of this study is to evaluate Legionella PCR techniques, performed directly onto the sputum aspirates, for the routine diagnosis of pneumonia in adults' patients admitted to hospital. This study implicates 3 University hospitals (Lyon, Grenoble and Saint-Etienne) in collaboration with the French reference center of legionellosis for a previous duration of one year. In addition to the usual diagnostic tests that are performed when pneumonia is suspected, real-time PCR will be added for the detection and differentiation of Legionella. Hypothesizing the inclusion of 1000 pneumonia in this study, the predictable number of newly-detected legionellosis will be approximately 60 to 70 cases. According to a predefined algorithm, cases of legionellosis will be classified as definite or probable. Sensitivity and specificity of the real-time PCR will be calculated according to this classification. This study is intended to validate real-time PCR as a tool for the rapid diagnosis of legionellosis, allowing to optimize the antibiotic treatment of pneumonia. PCR techniques can also contribute to the better detection and differentiation of Legionella sp infections that are not documented accurately by routine microbiologic tests.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

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

  • Written informed consent
  • Patient affiliated to social insurance
  • Community acquired or nosocomial pneumonia

排除标准

  • No sputum aspirate

结局指标

主要结局

Definite or probable legionellosis

时间窗: Inclusion and J30

次要结局

  • Definite legionellosis(Inclusion and J30)
  • Probable legionellosis(Inclusion and J30)
  • Possible legionellosis(Inclusion and J30)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (12)

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