Evaluation of Legionella PCR Techniques for the Routine Diagnosis of Legionellosis

Not Applicable

Terminated

• Conditions: Legionellosis
• Interventions: Procedure: Characterization Legionnella

• Registration Number: NCT00452153
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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 available

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-03-26
• Study First Submitted QC: 2007-03-26
• Study First Posted: 2007-03-27
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-28
• Last Update Posted: 2015-07-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

• No sputum aspirate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Characterization Legionnella	Characterization Legionnella	Characterization Legionnella by polymerase chain reaction (PCR)

Primary Outcome Measures

Name	Time	Method
Definite or probable legionellosis	Inclusion and J30

Secondary Outcome Measures

Name	Time	Method
Definite legionellosis	Inclusion and J30
Probable legionellosis	Inclusion and J30
Possible legionellosis	Inclusion and J30

Trial Locations

Locations (6)

HMU CHU Saint-Etienne; 🇫🇷 Saint-etienne, France

Infectious Disease unit CHU de Saint-Etienne; 🇫🇷 Saint-etienne, France

Reanimation unit - Hopital Bellevue - CHU de Saint-Etienne; 🇫🇷 Saint-etienne, France

Pneumology unit CHU de Saint-Etienne; 🇫🇷 Saint-etienne, France

Reanimation unit - Hôpital NORD - CHU de Saint-Etienne; 🇫🇷 Saint-etienne, France

Urgency unit CHU Saint-Etienne; 🇫🇷 Saint-etienne, France