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| Tracking Information | |||||||||
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| First Received Date ICMJE | March 26, 2007 | ||||||||
| Last Updated Date | June 8, 2009 | ||||||||
| Start Date ICMJE | March 2007 | ||||||||
| Estimated Primary Completion Date | July 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Definite or probable legionellosis [ Time Frame: Inclusion and J30 ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Definite or probable legionellosis | ||||||||
| Change History | Complete list of historical versions of study NCT00452153 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||||||
| Brief Title ICMJE | Evaluation of Legionella PCR Techniques for the Routine Diagnosis of Legionellosis | ||||||||
| Official Title ICMJE | Evaluation of Legionella PCR Techniques for the Routine Diagnosis of Legionellosis | ||||||||
| 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. |
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| Detailed Description | |||||||||
| Study Phase | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Control: Uncontrolled Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE | Legionellosis | ||||||||
| Intervention ICMJE | Procedure: Characterization Legionnella
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| Study Arms / Comparison Groups | Characterization Legionnella: Experimental
Intervention: Procedure: Characterization Legionnella |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 913 | ||||||||
| Estimated Completion Date | July 2010 | ||||||||
| Estimated Primary Completion Date | July 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00452153 | ||||||||
| Responsible Party | Clément CAILLAUX, CHU Saint-Etienne | ||||||||
| Study ID Numbers ICMJE | 0601072 | ||||||||
| Study Sponsor ICMJE | Centre Hospitalier Universitaire de Saint Etienne | ||||||||
| Collaborators ICMJE | Ministry of Health, France | ||||||||
| Investigators ICMJE |
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| Information Provided By | Centre Hospitalier Universitaire de Saint Etienne | ||||||||
| Verification Date | June 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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