Clinical Trial: Severe Legionellosis Cases Admitted to Grenoble University Hospital, 2006-2011.

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Molecular Epidemiology of Legionellosis in Grenoble Region

Brief Summary: The study aimed at further describing the epidemiological, clinical, diagnostic and prognostic features in legionellosis cases admitted to Grenoble University Hospital during the 2006-2011period. The investigators also tested lower respiratory samples collected from these patients during their routine medical care, using a number of molecular tools allowing determination of the involved Legionella species, the bacterial load, and the presence of antibiotic resistant mutants. Our primary goal was to define biological markers that could predict severity and outcome of infection in legionellosis cases requiring hospitalization.

Detailed Summary:

Patients admitted to Grenoble University Hospital between 2006 and 2011 for severe legionellosis were retrospectively included in the study.

Clinical, epidemiological, diagnostic and prognostic data of these patients were recorded retrospectively.

Lower respiratory samples collected from these patients on a routine basis for microbiological analysis, especially Legionella culture, were tested using traditional microbiological methods. The remaining part of these samples was stored at -80°C fur further molecular analyses.

The molecular tools developed by our bacteriology laboratory included the following: a real-time polymerase chain reaction (qPCR) test allowing detection and differentiation of L. pneumophila and other Legionella species; a qPCR test allowing determination of the Legionella DNA load in lower respiratory samples; a qPCR allowing detection of gyrA (the gene encoding subunit A of DNA gyrase) mutations that the investigators previously determined to be correlated with fluoroquinolones resistance in L. pneumophila; a high-throughput sequencing approach allowing confirmation of gyrA mutations and determination of the percentage of mutated alleles.

The microbiological data, especially those obtained with the developped molecular tools, were tentatively correlated with the severity and outcome of infection in our patients' cohort.


Sponsor: University Hospital, Grenoble

Current Primary Outcome: Legionella DNA load in lower respiratory tract samples [ Time Frame: through study completion, an average of 1 year ]

Real-time polymerase chain reaction (qPCR) dosages in lower respiratory tract samples collected on a routine basis all over the hospitalization duration


Original Primary Outcome: Same as current

Current Secondary Outcome: Fluoroquinolones resistant gyrA mutants in lower respiratory tract samples [ Time Frame: through study completion, an average of 1 year ]

Real-time polymerase chain reaction (qPCR) and high-throughput DNA sequencing testing of lower respiratory tract samples collected on a routine basis all over the hospitalization duration


Original Secondary Outcome: Same as current

Information By: University Hospital, Grenoble

Dates:
Date Received: August 22, 2016
Date Started: September 2009
Date Completion:
Last Updated: August 30, 2016
Last Verified: August 2016