Evaluation of Legionella PCR Techniques for the Routine Diagnosis of Legionellosis
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Purpose
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 | Intervention |
|---|---|
|
Legionellosis |
Procedure: Characterization Legionnella |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Evaluation of Legionella PCR Techniques for the Routine Diagnosis of Legionellosis |
- Definite or probable legionellosis [ Time Frame: Inclusion and J30 ] [ Designated as safety issue: No ]
- 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 ]
| Estimated Enrollment: | 913 |
| Study Start Date: | March 2007 |
| Estimated Study Completion Date: | July 2010 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Characterization Legionnella |
Procedure: Characterization Legionnella
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Written informed consent
- Patient affiliated to social insurance
- Community acquired or nosocomial pneumonia
Exclusion Criteria:
- No sputum aspirate
Contacts and Locations| France | |
| Urgency unit CHU Saint-Etienne | |
| Saint-etienne, France, 42055 | |
| Pneumology unit CHU de Saint-Etienne | |
| Saint-etienne, France, 42055 | |
| Infectious Disease unit CHU de Saint-Etienne | |
| Saint-etienne, France, 42055 | |
| HMU CHU Saint-Etienne | |
| Saint-etienne, France, 42055 | |
| Reanimation unit - Hôpital NORD - CHU de Saint-Etienne | |
| Saint-etienne, France, 42055 | |
| Reanimation unit - Hopital Bellevue - CHU de Saint-Etienne | |
| Saint-etienne, France, 42055 | |
| Principal Investigator: | Philippe Berthelot, PU-PH | CHU-Saint-Etienne |
More Information
Publications:
| Responsible Party: | Clément CAILLAUX, CHU Saint-Etienne |
| ClinicalTrials.gov Identifier: | NCT00452153 History of Changes |
| Other Study ID Numbers: | 0601072 |
| Study First Received: | March 26, 2007 |
| Last Updated: | September 28, 2010 |
| Health Authority: | France: Ministry of Health |
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 |
ClinicalTrials.gov processed this record on May 16, 2013