An interventional study of Characterization Legionnella in Legionellosis, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Terminated at 6 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-07-29.
Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Not applicable, Interventional, and Diagnostic
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.
Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 578 studies on the registry; 128 are open to participants now.
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Exclusion Criteria:
Characterization Legionnella by polymerase chain reaction (PCR)
Procedure: Characterization Legionnella
* Characterisation Legionnella by polymerase chain reaction (PCR) * Characterization strain of Legionnella by sequencing the 23S-5S ribosomal intergenic spacer region
Definite or probable legionellosis
Time frame: Inclusion and J30
Definite legionellosis
Time frame: Inclusion and J30
Probable legionellosis
Time frame: Inclusion and J30
Possible legionellosis
Time frame: Inclusion and J30
This study is terminated, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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Legionellosis
Centre Hospitalier Universitaire de Saint Etienne