Informations générales (source: ClinicalTrials.gov)
Bacterial and Human Biomarkers of Prognostic Value for Severe Legionnaire's Disease (Proglegio)
Interventional
N/A
Hospices Civils de Lyon (Voir sur ClinicalTrials)
août 2017
janvier 2025
08 février 2025
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Bichat | Jean Francois TIMSIT | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Tenon | Muriel FARTOUKH | Contact (sur clinicalTrials) | |||
| IFSI DE L'HÔPITAL SAINT LOUIS | Virginie LEMIALE, MD | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier Lyon Sud - Pierre-Bénite - France | Arnaud FRIGGERI | Contact (sur clinicalTrials) | |||
| CH Gustave Dron - Tourcoing - France | Serge ALFANDARI | Contact (sur clinicalTrials) | |||
| CHRU Besancon - Besançon - France | Gilles CAPELLIER | Contact (sur clinicalTrials) | |||
| CHU Brest - Brest - France | Francis COUTURAUD | Contact (sur clinicalTrials) | |||
| CHU d'Angouleme - Angoulême - France | David SCHNELL | Contact (sur clinicalTrials) | |||
| CHU de Nantes - Nantes - France | Francois-Xavier BLANC | Contact (sur clinicalTrials) | |||
| CHU Dijon - Dijon - France | Jean Pierre Quenot | Contact (sur clinicalTrials) | |||
| CHU Lille - Lille - France | Nseir SAADALLAH | Contact (sur clinicalTrials) | |||
| CHU Rennes - Rennes - France | Arnaud Gacouin | Contact (sur clinicalTrials) | |||
| CHU Strasbourg Nouvel Hôpital Civil - Strasbourg - France | Ferhat MEZIANI | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU Amiens - Amiens - France | Claire Andrejak | Contact (sur clinicalTrials) | |||
| CHU Grenoble - Grenoble - France | Carole SCHWEBEL | Contact (sur clinicalTrials) | |||
| CHU Saint Etienne - 42000 - Saint-Étienne - France | Frederic LUCHT | Contact (sur clinicalTrials) | |||
| Hôpital de la Croix Rousse - 69000 - Lyon - France | Jean-Christophe RICHARD | Contact (sur clinicalTrials) | |||
| Hopital Edouard Heriot - 69000 - Lyon - France | Laurent ARGAUD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- 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.
- 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.
- None Legionella pneumophila Legionnaires' disease.
- Patients for whom respiratory secretions can't be obtained.
- Cases diagnosed only by serology.
- Outpatients.