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Evaluation of Legionella PCR Techniques for the Routine Diagnosis of Legionellosis

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ClinicalTrials.gov Identifier: NCT00452153
Recruitment Status : Terminated (Too much difficulties to includ patient)
First Posted : March 27, 2007
Last Update Posted : July 29, 2015
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Legionellosis Procedure: Characterization Legionnella Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Legionella PCR Techniques for the Routine Diagnosis of Legionellosis
Study Start Date : March 2007
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Characterization Legionnella
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



Primary Outcome Measures :
  1. Definite or probable legionellosis [ Time Frame: Inclusion and J30 ]

Secondary Outcome Measures :
  1. Definite legionellosis [ Time Frame: Inclusion and J30 ]
  2. Probable legionellosis [ Time Frame: Inclusion and J30 ]
  3. Possible legionellosis [ Time Frame: Inclusion and J30 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • No sputum aspirate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00452153


Locations
France
HMU CHU Saint-Etienne
Saint-etienne, France, 42055
Infectious Disease unit CHU de Saint-Etienne
Saint-etienne, France, 42055
Pneumology unit CHU de Saint-Etienne
Saint-etienne, France, 42055
Reanimation unit - Hopital Bellevue - CHU de Saint-Etienne
Saint-etienne, France, 42055
Reanimation unit - Hôpital NORD - CHU de Saint-Etienne
Saint-etienne, France, 42055
Urgency unit CHU Saint-Etienne
Saint-etienne, France, 42055
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Ministry of Health, France
Investigators
Principal Investigator: Philippe Berthelot, PU-PH CHU-Saint-Etienne

Publications:

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT00452153     History of Changes
Other Study ID Numbers: 0601072
First Posted: March 27, 2007    Key Record Dates
Last Update Posted: July 29, 2015
Last Verified: July 2015

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
legionellosis
diagnosis of legionellosis
PCR

Additional relevant MeSH terms:
Legionellosis
Legionnaires' Disease
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Respiratory Tract Diseases