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Evaluation of Legionella PCR Techniques for the Routine Diagnosis of Legionellosis

Evaluation of Legionella PCR Techniques for the Routine Diagnosis of Legionellosis

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00452153
Enrollment
200
Registered
2007-03-27
Start date
2007-03-31
Completion date
2010-07-31
Last updated
2015-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Legionellosis

Keywords

legionellosis, diagnosis of legionellosis, PCR

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.

Interventions

PROCEDURECharacterization Legionnella

* Characterisation Legionnella by polymerase chain reaction (PCR) * Characterization strain of Legionnella by sequencing the 23S-5S ribosomal intergenic spacer region

Sponsors

Ministry of Health, France
CollaboratorOTHER_GOV
Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* No sputum aspirate

Design outcomes

Primary

MeasureTime frame
Definite or probable legionellosisInclusion and J30

Secondary

MeasureTime frame
Definite legionellosisInclusion and J30
Probable legionellosisInclusion and J30
Possible legionellosisInclusion and J30

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026