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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

Tracking Information
First Submitted Date  ICMJE March 26, 2007
First Posted Date  ICMJE March 27, 2007
Last Update Posted Date July 29, 2015
Study Start Date  ICMJE March 2007
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2009)
Definite or probable legionellosis [ Time Frame: Inclusion and J30 ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 26, 2007)
Definite or probable legionellosis
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2009)
  • Definite legionellosis [ Time Frame: Inclusion and J30 ]
  • Probable legionellosis [ Time Frame: Inclusion and J30 ]
  • Possible legionellosis [ Time Frame: Inclusion and J30 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2007)
  • Definite legionellosis
  • Probable legionellosis
  • Possible legionellosis
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Legionellosis
Intervention  ICMJE Procedure: Characterization Legionnella
  • Characterisation Legionnella by polymerase chain reaction (PCR)
  • Characterization strain of Legionnella by sequencing the 23S-5S ribosomal intergenic spacer region
Study Arms  ICMJE 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
Actual Enrollment  ICMJE
 (submitted: July 27, 2015)
200
Original Enrollment  ICMJE
 (submitted: March 26, 2007)
913
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • No sputum aspirate
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE 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  ICMJE 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
Principal Investigator: Philippe Berthelot, PU-PH CHU-Saint-Etienne
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