Evaluation of Legionella PCR Techniques for the Routine Diagnosis of Legionellosis

This study has been terminated.
(Study has been stopped because investigators have too mluch difficulties to includ patient)
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by:
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT00452153
First received: March 26, 2007
Last updated: September 28, 2010
Last verified: September 2010
  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

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • Definite or probable legionellosis [ Time Frame: Inclusion and J30 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
  • Characterisation Legionnella by polymerase chain reaction (PCR)
  • Characterization strain of Legionnella by sequencing the 23S-5S ribosomal intergenic spacer region

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00452153

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
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Ministry of Health, France
Investigators
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 September 22, 2014