Evaluation of Legionella PCR Techniques for the Routine Diagnosis of Legionellosis

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.

Study Overview

Status

Terminated

Conditions

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Saint-etienne, France, 42055
        • HMU CHU Saint-Etienne
      • Saint-etienne, France, 42055
        • Infectious Disease unit CHU de Saint-Etienne
      • Saint-etienne, France, 42055
        • Pneumology unit CHU de Saint-Etienne
      • Saint-etienne, France, 42055
        • Reanimation unit - Hopital Bellevue - CHU de Saint-Etienne
      • Saint-etienne, France, 42055
        • Reanimation unit - Hôpital NORD - CHU de Saint-Etienne
      • Saint-etienne, France, 42055
        • Urgency unit CHU Saint-Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • No sputum aspirate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Characterization Legionnella
Characterization Legionnella by polymerase chain reaction (PCR)
  • Characterisation Legionnella by polymerase chain reaction (PCR)
  • Characterization strain of Legionnella by sequencing the 23S-5S ribosomal intergenic spacer region

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Definite or probable legionellosis
Time Frame: Inclusion and J30
Inclusion and J30

Secondary Outcome Measures

Outcome Measure
Time Frame
Definite legionellosis
Time Frame: Inclusion and J30
Inclusion and J30
Probable legionellosis
Time Frame: Inclusion and J30
Inclusion and J30
Possible legionellosis
Time Frame: Inclusion and J30
Inclusion and J30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Philippe Berthelot, PU-PH, CHU-Saint-Etienne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (ACTUAL)

July 1, 2010

Study Completion (ACTUAL)

July 1, 2010

Study Registration Dates

First Submitted

March 26, 2007

First Submitted That Met QC Criteria

March 26, 2007

First Posted (ESTIMATE)

March 27, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

July 29, 2015

Last Update Submitted That Met QC Criteria

July 28, 2015

Last Verified

July 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Legionellosis

Clinical Trials on Characterization Legionnella

3
Subscribe