Legionnaires' DiseaseLEGIOGRENCT02884700
Severe Legionellosis Cases Admitted to Grenoble University Hospital, 2006-2011.
An observational study of Legionnaires' Disease, run by University Hospital, Grenoble.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Legionnaires' Disease
- What is being tested?
- Real-time PCR testing of lower respiratory tract samples
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 82 unrelated legionellosis cases 64 males, 18 females mean age: 55 years, range: 27-97 years severe legionellosis requiring hospitalization
Who may be able to join
- age higher than 18 years
- proven legionellosis case (positive culture and/or PCR and/or urinary antigen test)
- severe case requiring hospitalization
Who cannot join
- age under 18 years
- pregnant women
About this study
Official title: Molecular Epidemiology of Legionellosis in Grenoble Region
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.
- Conditions
- Legionnaires' Disease
- Being tested
- Real-time PCR testing of lower respiratory tract samples
- Keywords
- Legionella, Legionnaires' disease, Diagnosis, Prognosis
- Medical subject headings
- Legionnaires' Disease, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-time PCR testing of lower respiratory tract samplesBiological
qPCR and high-throughput DNA sequencing testing of lower respiratory tract samples collected routinely in patients with severe legionellosis
| Study group | Role | What they receive |
|---|---|---|
| Severe legionellosis cases | Patients admitted to Grenoble University Hospital for severe legionellosis between 2006 and 2011. Receives: Biological: Real-time PCR testing of lower respiratory tract samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study startSep 2009
- Primary completionDec 2011
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Legionnaires' DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AdministrateurDRC, University Hospital, Grenoble
- Investigators
- Hélène Sabbah-Guillaume, Director, Study director, Direction of Research and Medical Innovation (DRCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02884700
- Sponsor's protocol ID
- Grenobole University Hospital
- Acronym
- LEGIOGRE
- Status last verified
- Aug 2016
- First submitted
- 22 Aug 2016
- Last updated
- 31 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Biological data are available at the bacteriology laboratory. Clinical data are available at the participating medical wards.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Epidemiology of Legionellosis in Grenoble Region
- ClinicalTrials.gov ID
- NCT02884700
- Acronym / sponsor ID
- LEGIOGRE / Grenobole University Hospital
- Conditions
- Legionnaires' Disease
- Keywords
- Legionella, Legionnaires' disease, Diagnosis, Prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 31 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe legionellosis cases | – | Biological: Real-time PCR testing of lower respiratory tract samplesPatients admitted to Grenoble University Hospital for severe legionellosis between 2006 and 2011. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 82 unrelated legionellosis cases 64 males, 18 females mean age: 55 years, range: 27-97 years severe legionellosis requiring hospitalization
Key inclusion criteria (3 listed)
- age higher than 18 years
- proven legionellosis case (positive culture and/or PCR and/or urinary antigen test)
- severe case requiring hospitalization
Key exclusion criteria (2 listed)
- age under 18 years
- pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real-time PCR testing of lower respiratory tract samplesqPCR and high-throughput DNA sequencing testing of lower respiratory tract samples collected routinely in patients with severe legionellosis | Biological | Severe legionellosis cases |
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
1 secondary outcome
Fluoroquinolones resistant gyrA mutants in lower respiratory tract samples
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2016.
- Individual participant dataSharing planned: No. Biological data are available at the bacteriology laboratory. Clinical data are available at the participating medical wards.
Related trials for Legionnaires' Disease
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hélène Sabbah-Guillaume, Director study director
Direction of Research and Medical Innovation (DRCI)
Questions about this trial
What is this clinical trial studying?
An observational study of Legionnaires' Disease, run by University Hospital, Grenoble.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Legionella DNA load in lower respiratory tract samples (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2016.