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OpenTrials
Completed

NCT Number: NCT02884700

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age higher than 18 years
  • proven legionellosis case (positive culture and/or PCR and/or urinary antigen test)
  • severe case requiring hospitalization

Exclusion criteria

  • age under 18 years
  • pregnant women

Treatment and study plan

Real-time PCR testing of lower respiratory tract samples

Biological

qPCR and high-throughput DNA sequencing testing of lower respiratory tract samples collected routinely in patients with severe legionellosis

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

Molecular Epidemiology of Legionellosis in Grenoble Region

Acronym: LEGIOGRE

Important dates

Study start
2009
Primary completion
2011
Study completion
2014
First posted
Aug 31, 2016
Registry last updated
Aug 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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