Evaluation of Legionella PCR Techniques for the Routine Diagnosis of Legionellosis

This study has been terminated.
(Study has been stopped because investigators have too mluch difficulties to includ patient)
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by:
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT00452153
First received: March 26, 2007
Last updated: September 28, 2010
Last verified: September 2010

March 26, 2007
September 28, 2010
March 2007
July 2010   (final data collection date for primary outcome measure)
Definite or probable legionellosis [ Time Frame: Inclusion and J30 ] [ Designated as safety issue: No ]
Definite or probable legionellosis
Complete list of historical versions of study NCT00452153 on ClinicalTrials.gov Archive Site
  • Definite legionellosis [ Time Frame: Inclusion and J30 ] [ Designated as safety issue: No ]
  • Probable legionellosis [ Time Frame: Inclusion and J30 ] [ Designated as safety issue: No ]
  • Possible legionellosis [ Time Frame: Inclusion and J30 ] [ Designated as safety issue: No ]
  • Definite legionellosis
  • Probable legionellosis
  • Possible legionellosis
Not Provided
Not Provided
 
Evaluation of Legionella PCR Techniques for the Routine Diagnosis of Legionellosis
Evaluation of Legionella PCR Techniques for the Routine Diagnosis of Legionellosis

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Legionellosis
Procedure: Characterization Legionnella
  • Characterisation Legionnella by polymerase chain reaction (PCR)
  • Characterization strain of Legionnella by sequencing the 23S-5S ribosomal intergenic spacer region
Experimental: Characterization Legionnella
Intervention: Procedure: Characterization Legionnella

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
913
July 2010
July 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • No sputum aspirate
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00452153
0601072
No
Clément CAILLAUX, CHU Saint-Etienne
Centre Hospitalier Universitaire de Saint Etienne
Ministry of Health, France
Principal Investigator: Philippe Berthelot, PU-PH CHU-Saint-Etienne
Centre Hospitalier Universitaire de Saint Etienne
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP