LegionellaProglegioNCT03064737
Bacterial and Human Biomarkers of Prognostic Value for Severe Legionnaire's Disease
A study testing Skin biopsy for genetic analyze in people with Legionella, run by Hospices Civils de Lyon at 19 sites in France.
Trial summary
Legionnaires' disease (LD) is a relatively common pneumonia in France (1200 cases/year), 98% of cases are hospitalized and 40% require intensive care unit (ICU) admission. Risk factors that may predispose to acquisition of LD are well known. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Legionella
- What is being tested?
- Skin biopsy for genetic analyze
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 19 sitesFrance
- Study dates
- 23 Aug 2017to 31 Jan 2025
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult patients with medical and biological signs of legionnaires' disease.
- Pediatric patients regardless of age but with a minimum weight of 7.5 kg with medical and biological signs of legionnaires' disease.
- Patient and/or his/her legal representative have reviewed the patient information/informed consent form and have given written informed consent.
Who cannot join
- None Legionella pneumophila Legionnaires' disease.
- Patients for whom respiratory secretions can't be obtained.
- Cases diagnosed only by serology.
- Outpatients.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
France19 sites, 19 recruiting
- Recruiting
CHU Amiens
Amiens
Claire Andrejak
Claire Andrejak
- Recruiting
CHU d'Angouleme
Angoulême
David SCHNELL
David SCHNELL
- Recruiting
CHRU Besancon
Besançon
Gilles CAPELLIER
Gilles CAPELLIER
- Recruiting
CHU Brest
Brest
Francis COUTURAUD
Francis COUTURAUD
- Recruiting
CHU Dijon
Dijon
Mathieu BLOT
Mathieu BLOT
- Recruiting
CHU Dijon
Dijon
Jean Pierre Quenot
Jean Pierre Quenot
- Recruiting
CHU Grenoble
Grenoble
Carole SCHWEBEL
Carole SCHWEBEL
- Recruiting
CHU Lille
Lille
Nseir SAADALLAH
Nseir SAADALLAH
- Recruiting
Hopital Edouard Heriot
Lyon, 69000
Laurent ARGAUD
Laurent ARGAUD
- Recruiting
Hôpital de la Croix Rousse
Lyon, 69000
Jean-Christophe RICHARD
Jean-Christophe RICHARD
- Recruiting
CHU de Nantes
Nantes
Francois-Xavier BLANC
Francois-Xavier BLANC
- Recruiting
Hôpital Saint Louis - APHP
Paris, 75010
Virginie LEMIALE, MD
Virginie LEMIALE, MD
- Recruiting
Hôpital Tenon
Paris, 75020
Muriel FARTOUKH
Muriel FARTOUKH
- Recruiting
APHP Hôpital Bichat
Paris
Jean Francois TIMSIT
Jean Francois TIMSIT
- Recruiting
Centre Hospitalier Lyon Sud
Pierre-Bénite
Arnaud FRIGGERI
Arnaud FRIGGERI
- Recruiting
CHU Rennes
Rennes
Arnaud Gacouin
Arnaud Gacouin
- Recruiting
CHU Saint Etienne
Saint-Etienne, 42000
Frederic LUCHT
Frederic LUCHT
- Recruiting
CHU Strasbourg Nouvel Hôpital Civil
Strasbourg
Ferhat MEZIANI
Ferhat MEZIANI
- Recruiting
CH Gustave Dron
Tourcoing
Serge ALFANDARI
Serge ALFANDARI
About this study
Legionnaires' disease (LD) is a relatively common pneumonia in France (1200 cases/year), 98% of cases are hospitalized and 40% require intensive care unit (ICU) admission. Risk factors that may predispose to acquisition of LD are well known. Some studies suggest that genetic factor may also enhance susceptibility to LD.
The mortality rate remains high (10% to 33% in ICUs) despite improved diagnostic and therapeutic management of patients. Few prospective studies have assessed the factors associated with LD outcomes, particularly death, and most of them involved a limited number of patients.
Read more
In a multicentre cohort study, the investigators recently identified risk factors associated with higher mortality such as female sex, age, ICU stay, renal failure, corticosteroid treatment and enhanced pro-inflammatory status, as assessed by higher C-reactive protein level (PMID: 22005914). Other factors are suspected but their involvement has not been formally demonstrated including a high infectious bacterial load, particular virulence of Legionella strain, and an in vivo selection of mutants resistant to prescribed antibiotics. Disease progression is highly variable from one patient to another, and usually remains unpredictable. There are no objective criteria to predict the prognosis of these patients.
The clinical course of patients with LD remains difficult to predict because no predictive biomarkers have yet been characterized and the demonstration of the presence of mutants to antibiotics in vivo has never been done.
The main objective of the study is to correlate the L. pneumophila load (detected by PCR) to the clinical outcome of the LD infection. Clinical severity will measured by the SOFA score (Sepsis -Related Organ Failure Assessment) or the PELOD score (Pediatric Logistic Organ Dysfunction).
Secondary objectives are to identify new host and bacterial biomarkers associated with poor outcome of LD.
- Conditions
- Legionella
- Being tested
- Skin biopsy for genetic analyze
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin biopsy for genetic analyzeOther
It will be offered to a subgroup of adult patients carrying genetic markers predisposing to the severity of the LD infection, a skin biopsy in order to realize genetic analyses.
This visit will be conducted once the results of genetic markers obtained (between 30 and 36 months), a specific consent will be required to patients.
The skin biopsy will be performed according to the Clinical Department use.
| Study group | Role | What they receive |
|---|---|---|
| This study is a non-drug one arm study | Other | Skin biopsy for genetic analyze Receives: Other: Skin biopsy for genetic analyze |
What is being measured
The primary outcome is the main question the study is designed to answer.
Legionnaire's disease severity measured by SOFA/PELOD score
No other specific timeframe could be provided, it will depend on patients' condition. The study will evaluate correlation between the L. pneumophila load (quantify by molecular method) to the clinical outcome of the LD infection
Measured: At Hospital Output, on average 1 Day
Bacterial load measured by PCR
No other specific timeframe could be provided, it will depend on patients' condition. The study will evaluate correlation between the L. pneumophila load (quantify by molecular method) to the clinical outcome of the LD infection
Measured: At Hospital Output, on average 1 Day
Secondary outcomes (3)
Specific cytokine profile
Cytokine profile will be measured at local level (pulmonary) and/ or systemic level (serum) and associated with severity
Measured: Up to Day 5
Genomic analyzes
Genomic analyzes of bacterial genes will be associated with the legionella severity
Measured: At inclusion, up to 48 hours
Pulmonary microbiota
Metagenomic approaches and NGS will be used to associate a specific microbiota, or changes in the severity of LD infection
Measured: At inclusion, up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2017
- Study start23 Aug 2017
- Primary completion31 Jan 2024 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LegionellaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gérard LINA, Study chair, Hospices Civils of Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03064737
- Sponsor's protocol ID
- 69HCL16_0131
- Acronym
- Proglegio
- Status last verified
- May 2022
- First submitted
- 2 Sep 2016
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacterial and Human Biomarkers of Prognostic Value for Severe Legionnaire's Disease
- ClinicalTrials.gov ID
- NCT03064737
- Acronym / sponsor ID
- Proglegio / 69HCL16_0131
- Conditions
- Legionella
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 23 Aug 2017 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 27 Feb 2017 (actual)
- 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.
Legionnaires' disease (LD) is a relatively common pneumonia in France (1200 cases/year), 98% of cases are hospitalized and 40% require intensive care unit (ICU) admission. Risk factors that may predispose to acquisition of LD are well known. Some studies suggest that genetic factor may also enhance susceptibility to LD.
The mortality rate remains high (10% to 33% in ICUs) despite improved diagnostic and therapeutic management of patients. Few prospective studies have assessed the factors associated with LD outcomes, particularly death, and most of them involved a limited number of patients.
In a multicentre cohort study, the investigators recently identified risk factors associated with higher mortality such as female sex, age, ICU stay, renal failure, corticosteroid treatment and enhanced pro-inflammatory status, as assessed by higher C-reactive protein level (PMID: 22005914). Other factors are suspected but their involvement has not been formally demonstrated including a high infectious bacterial load, particular virulence of Legionella strain, and an in vivo selection of mutants resistant to prescribed antibiotics. Disease progression is highly variable from one patient to another, and usually remains unpredictable. There are no objective criteria to predict the prognosis of these patients.
The clinical course of patients with LD remains difficult to predict because no predictive biomarkers have yet been characterized and the demonstration of the presence of mutants to antibiotics in vivo has never been done.
The main objective of the study is to correlate the L. pneumophila load (detected by PCR) to the clinical outcome of the LD infection. Clinical severity will measured by the SOFA score (Sepsis -Related Organ Failure Assessment) or the PELOD score (Pediatric Logistic Organ Dysfunction).
Secondary objectives are to identify new host and bacterial biomarkers associated with poor outcome of LD.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| This study is a non-drug one arm study | Other | Other: Skin biopsy for genetic analyzeSkin biopsy for genetic analyze |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients with medical and biological signs of legionnaires' disease.
- Pediatric patients regardless of age but with a minimum weight of 7.5 kg with medical and biological signs of legionnaires' disease.
- Patient and/or his/her legal representative have reviewed the patient information/informed consent form and have given written informed consent.
Key exclusion criteria (4 listed)
- None Legionella pneumophila Legionnaires' disease.
- Patients for whom respiratory secretions can't be obtained.
- Cases diagnosed only by serology.
- Outpatients.
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 |
|---|---|---|
| Skin biopsy for genetic analyzeIt will be offered to a subgroup of adult patients carrying genetic markers predisposing to the severity of the LD infection, a skin biopsy in order to realize genetic analyses. This visit will be conducted once the results of genetic markers obtained (between 30 and 36 months), a specific consent will be required to patients. The skin biopsy will be performed according to the Clinical Department use. | Other | This study is a non-drug one arm study |
Primary outcome
Legionnaire's disease severity measured by SOFA/PELOD score
Time frame: At Hospital Output, on average 1 Day
No other specific timeframe could be provided, it will depend on patients' condition. The study will evaluate correlation between the L. pneumophila load (quantify by molecular method) to the clinical outcome of the LD infection
Bacterial load measured by PCR
Time frame: At Hospital Output, on average 1 Day
No other specific timeframe could be provided, it will depend on patients' condition. The study will evaluate correlation between the L. pneumophila load (quantify by molecular method) to the clinical outcome of the LD infection
3 secondary outcomes
Specific cytokine profile
Time frame: Up to Day 5
Genomic analyzes
Time frame: At inclusion, up to 48 hours
Pulmonary microbiota
Time frame: At inclusion, up to 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
Related trials for Legionella
RecruitingObservational study
Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective
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Not yet recruiting
Volatile Organic Compounds Analysis by GC-MS for Diagnostic of Hospitalised Patients With Respiratory Infections Using Exhaled Breath
Respiratory Infections, COVID-19
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.
Gérard LINA study chair
Hospices Civils of Lyon
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin biopsy for genetic analyze in people with Legionella, run by Hospices Civils de Lyon at 19 sites in France.
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 4 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: status not confirmed, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gérard LINA, MD PhD (+33 4 78 86 44 93, gerard.lina@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Legionnaire's disease severity measured by SOFA/PELOD score (time frame: At Hospital Output, on average 1 Day). The study lists 2 primary outcomes in all. 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 5 May 2022.