Evaluation of Legionella PCR Techniques for the Routine Diagnosis of Legionellosis

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2010

Interventions

  • Procedure: Characterization Legionnella
    • Characterisation Legionnella by polymerase chain reaction (PCR) Characterization strain of Legionnella by sequencing the 23S-5S ribosomal intergenic spacer region

Arms, Groups and Cohorts

  • Experimental: Characterization Legionnella
    • Characterization Legionnella by polymerase chain reaction (PCR)

Clinical Trial Outcome Measures

Primary Measures

  • Definite or probable legionellosis
    • Time Frame: Inclusion and J30

Secondary Measures

  • Definite legionellosis
    • Time Frame: Inclusion and J30
  • Probable legionellosis
    • Time Frame: Inclusion and J30
  • Possible legionellosis
    • Time Frame: Inclusion and J30

Participating in This Clinical Trial

Inclusion Criteria

  • Written informed consent – Patient affiliated to social insurance – Community acquired or nosocomial pneumonia Exclusion Criteria:

  • No sputum aspirate

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre Hospitalier Universitaire de Saint Etienne
  • Collaborator
    • Ministry of Health, France
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Philippe Berthelot, PU-PH, Principal Investigator, CHU-Saint-Etienne

References

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