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CompletedNCT02884700LEGIOGREUpdated Aug 31, 2016

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

An observational study in Legionnaires' Disease, sponsored by University Hospital, Grenoble. Completed. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2016-08-31.

Primary conditionnone(registry's first term: Disease)No conditionIs this wrong?Disease describes something many studies share rather than a condition a study is about. The study names no condition we can place it under, so it is not compared with other studies by condition.

Sponsored by University Hospital, Grenoble · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
82
Ages
18 Years to 99 Years
Sex
All
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Study 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.

Read the detailed description

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.

02

Conditions studied

  • Legionnaires' Disease

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Keywords

  • Legionella
  • Legionnaires' disease
  • Diagnosis
  • Prognosis
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In context

Lead sponsor

University Hospital, Grenoble is the lead sponsor of 837 studies on the registry; 207 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

82 unrelated legionellosis cases 64 males, 18 females mean age: 55 years, range: 27-97 years severe legionellosis requiring hospitalization

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • age under 18 years
  • pregnant women
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
82 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Severe legionellosis cases

    Patients admitted to Grenoble University Hospital for severe legionellosis between 2006 and 2011.

    Biological: Real-time PCR testing of lower respiratory tract samples

Interventions

  • BiologicalReal-time PCR testing of lower respiratory tract samples

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

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What researchers measure

Primary outcomes

  1. Legionella DNA load in lower respiratory tract samples

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

    Time frame: through study completion, an average of 1 year

Secondary outcomes

  1. Fluoroquinolones resistant gyrA mutants in lower respiratory tract samples

    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

    Time frame: through study completion, an average of 1 year

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No — Biological data are available at the bacteriology laboratory. Clinical data are available at the participating medical wards.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2009, a primary completion of Dec 2011 and a completion of Dec 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 22, 2016
First posted
Aug 31, 2016
Start
Sep 2009
Primary completionActual
Dec 2011
CompletionActual
Dec 2014
Last update
Aug 31, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 31, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02884700
Responsible party
AdministrateurDRC (Pr. Max Maurin, University Hospital, Grenoble) — Principal investigator
First posted
Aug 31, 2016
Start date
Sep 2009
Primary completion
Dec 2011
Completion
Dec 2014
Last update
Aug 31, 2016

Study contacts

Hélène Sabbah-Guillaume, Director
study director · Direction of Research and Medical Innovation (DRCI)

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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