IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
Evaluation of Legionella PCR Techniques for the Routine Diagnosis of Legionellosis
This study has been terminated.
(Too much difficulties to includ patient)
Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT00452153
First received: March 26, 2007
Last updated: July 28, 2015
Last verified: July 2015
| Tracking Information | ||||
|---|---|---|---|---|
| First Received Date ICMJE | March 26, 2007 | |||
| Last Updated Date | July 28, 2015 | |||
| Start Date ICMJE | March 2007 | |||
| 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 ] | |||
| 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 |
|
|||
| Original Secondary Outcome Measures ICMJE |
|
|||
| Current Other Outcome Measures ICMJE | Not Provided | |||
| Original Other Outcome Measures ICMJE | Not Provided | |||
| 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. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase | Not Provided | |||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
|||
| Condition ICMJE | Legionellosis | |||
| Intervention ICMJE | Procedure: Characterization Legionnella
|
|||
| Study Arms | Experimental: Characterization Legionnella
Characterization Legionnella by polymerase chain reaction (PCR)
Intervention: Procedure: Characterization Legionnella |
|||
| Publications * |
|
|||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Terminated | |||
| Enrollment ICMJE | 200 | |||
| Completion Date | July 2010 | |||
| Primary Completion Date | July 2010 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
|||
| Sex/Gender |
|
|||
| Ages | 18 Years and older (Adult, Senior) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | France | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00452153 | |||
| Other Study ID Numbers ICMJE | 0601072 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Centre Hospitalier Universitaire de Saint Etienne | |||
| Study Sponsor ICMJE | Centre Hospitalier Universitaire de Saint Etienne | |||
| Collaborators ICMJE | Ministry of Health, France | |||
| Investigators ICMJE |
|
|||
| PRS Account | Centre Hospitalier Universitaire de Saint Etienne | |||
| Verification Date | July 2015 | |||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
||||