Clinical trial NCT00452153: Evaluation of Legionella PCR Techniques for the Routine Diagnosis of Legionellosis
Official title: Evaluation of Legionella PCR Techniques for the Routine Diagnosis of Legionellosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Legionellosis
Keywords: legionellosis
diagnosis of legionellosis
PCR
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2007-03-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* No sputum aspirate

Primary outcomes:
measure: Definite or probable legionellosis
timeFrame: Inclusion and J30
Secondary outcomes:
measure: Definite legionellosis
timeFrame: Inclusion and J30
measure: Probable legionellosis
timeFrame: Inclusion and J30
measure: Possible legionellosis
timeFrame: Inclusion and J30
Other outcomes:
Locations:
city: Saint-etienne
country: France
facility: HMU CHU Saint-Etienne
city: Saint-etienne
country: France
facility: Infectious Disease unit CHU de Saint-Etienne
city: Saint-etienne
country: France
facility: Pneumology unit CHU de Saint-Etienne
city: Saint-etienne
country: France
facility: Reanimation unit - Hopital Bellevue - CHU de Saint-Etienne
city: Saint-etienne
country: France
facility: Reanimation unit - Hôpital NORD - CHU de Saint-Etienne
city: Saint-etienne
country: France
facility: Urgency unit CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Philippe Berthelot, PU-PH
role: PRINCIPAL_INVESTIGATOR
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