Bacterial and Human Biomarkers of Prognostic Value for Severe Legionnaire's Disease
NCT ID: NCT03064737
Last Updated: 2022-05-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
300 participants
INTERVENTIONAL
2017-08-23
2025-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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This study is a non-drug one arm study
Skin biopsy for genetic analyze
Skin biopsy for genetic analyze
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.
Interventions
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Skin biopsy for genetic analyze
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Patients for whom respiratory secretions can't be obtained.
* Cases diagnosed only by serology.
* Outpatients.
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Gérard LINA
Role: STUDY_CHAIR
Hospices Civils of Lyon
Locations
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CHU Amiens
Amiens, , France
CHU d'Angouleme
Angoulême, , France
CHRU Besancon
Besançon, , France
CHU Brest
Brest, , France
CHU Dijon
Dijon, , France
CHU Dijon
Dijon, , France
CHU Grenoble
Grenoble, , France
CHU Lille
Lille, , France
Hopital Edouard Heriot
Lyon, , France
Hôpital de la Croix Rousse
Lyon, , France
CHU de Nantes
Nantes, , France
Hôpital Saint Louis - APHP
Paris, , France
Hôpital Tenon
Paris, , France
APHP Hôpital Bichat
Paris, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
CHU Rennes
Rennes, , France
CHU Saint Etienne
Saint-Etienne, , France
CHU Strasbourg Nouvel Hôpital Civil
Strasbourg, , France
CH Gustave Dron
Tourcoing, , France
Countries
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Central Contacts
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Facility Contacts
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Claire Andrejak
Role: primary
David SCHNELL
Role: primary
Gilles CAPELLIER
Role: primary
Francis COUTURAUD
Role: primary
Mathieu BLOT
Role: primary
Jean Pierre Quenot
Role: primary
Carole SCHWEBEL
Role: primary
Nseir SAADALLAH
Role: primary
Laurent ARGAUD
Role: primary
Jean-Christophe RICHARD
Role: primary
Francois-Xavier BLANC
Role: primary
Virginie LEMIALE, MD
Role: primary
Muriel FARTOUKH
Role: primary
Jean Francois TIMSIT
Role: primary
Arnaud FRIGGERI
Role: primary
Arnaud Gacouin
Role: primary
Frederic LUCHT
Role: primary
Ferhat MEZIANI
Role: primary
Serge ALFANDARI
Role: primary
Other Identifiers
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69HCL16_0131
Identifier Type: -
Identifier Source: org_study_id
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