Evaluation of Legionella PCR Techniques for the Routine Diagnosis of Legionellosis

This study has been terminated.

(Too much difficulties to includ patient)

Sponsor:

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

History of Changes

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 ] [ 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

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 ]

Original Secondary Outcome Measures ^ICMJE

Definite legionellosis
Probable legionellosis
Possible legionellosis

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

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Arm (s)

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:

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

Exclusion Criteria:

No sputum aspirate

Gender

Both

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

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

Plan to Share Data

Not Provided

IPD Description

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

Information Provided By

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

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