Evaluation of Legionella PCR Techniques for the Routine Diagnosis of Legionellosis

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Legionella PCR Techniques for the Routine Diagnosis of Legionellosis

Conditions
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Legionellosis

Intervention / Treatment
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* Procedure: Characterization Legionnella


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent Patient affiliated to social insurance Community acquired or nosocomial pneumonia Exclusion Criteria: No sputum aspirate

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Characterization Legionnella<br>Characterization Legionnella by polymerase chain reaction (PCR) | Procedure: Characterization Legionnella<br>* Characterisation Legionnella by polymerase chain reaction (PCR) Characterization strain of Legionnella by sequencing the 23S-5S ribosomal intergenic spacer region<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Definite or probable legionellosis |  | Inclusion and J30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Definite legionellosis |  | Inclusion and J30 | 
| Probable legionellosis |  | Inclusion and J30 | 
| Possible legionellosis |  | Inclusion and J30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCR, legionellosis, diagnosis of legionellosis