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NCT03912506 Clinical Trial

Severe Leptospirosis in Non-tropical Areas

Intensive Care Unit Clinical Trial

— LEPTOREA  

Official title:
Severe Leptospirosis in Non-tropical Areas: a Nationwide, Multicentre, Retrospective Study in French ICUs

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03912506
Other study ID # LEPTOREA
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 7, 2017
Est. completion date July 9, 2018

Study information
Verified date May 2019
Source Nantes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Leptospirosis is a worldwide zoonosis. The mortality of the disease is between 3,6% to 13%, and up to 48% for the severe leptospirosis.

Only few studies exist on severe leptospirosis and none major multicentre on leptospirosis in intensive care units in Europe. The investigators conduct a retrospective multi centric study in metropolitan France in order to identify the characteristic, the treatments and the prognostic factors associated with mortality of sever leptospirosis.

Description:

Leptospirosis is a worldwide zoonosis. The infection is acquired through contact with animal urine on contaminated soil. It is an important remerging infectious disease because of its increasing incidence. Leptospirosis is most common in tropical and rural settings but its incidence has been constantly increasing for the past ten years in Metropolitan France. Most of the cases are asymptomatic or sparsely symptomatic, but some patients develop severe leptospirosis (6% to 59%), requiring hospitalisation in intensive care units. The mortality of the disease is between 3,6% to 13%, and up to 48% for the severe leptospirosis.

Only few studies exist on severe leptospirosis and none major multicentre on leptospirosis in intensive care units in Europe. Therefore, the investigators have decided to carry out this studies. The investigators conduct a retrospective multi centric study in metropolitan France in order to identify the characteristic, the treatments and the prognostic factors associated with mortality of sever leptospirosis.

Recruitment information / eligibility
Status Completed
Enrollment 160
Est. completion date July 9, 2018
Est. primary completion date July 9, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patient admitted in ICU

- Leptospirosis confirmed with one laboratory test (MAT, ELISA, PCR, direct examination)

Exclusion Criteria:

- No specific exclusion criteria

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France CHU Amiens-Picardie Amiens
France CHU Angers Angers
France CH Angoulème Angoulême
France CH Annecy Annecy
France CH Avignon Avignon
France hopital saint Leon, CH de la Cote Basque Bayonne
France CHU Besançon Besançon
France CH Fleyriat Bourg-en-Bresse
France CHU de Caen Caen
France CH Cahors Cahors
France CH Chartres Chartres
France CH Cholet Cholet
France CHD de la Vendée La Roche-sur-Yon
France Hopital Saint Louis La Rochelle
France CH Le Mans Le Mans
France CH Lens Lens
France CHU de Lille Lille
France Hopital Edouard Herriot, Hospices civils de Lyon Lyon
France GHR MSA Mulhouse
France CHRU de Nancy Nancy
France CH Niort Niort
France CHU Bicetre APHP Paris
France CHU Cochin APHP Paris
France CHU Henri Mondor Paris
France CHU Saint Louis, APHP Paris
France CH Périgueux Périgueux
France CH René-Dubost Pontoise
France CHU Rennes Rennes
France CHU Rouen Rouen
France CH Saint Brieuc Saint-Brieuc
France CH Saint Malo Saint-Malo
France CH Saint Nazaire Saint-Nazaire
France CHRU Bretonneau Tours
France CH Valenciennes Valenciennes
France CH Vannes Vannes
France Hopital André Mignot Versailles

Sponsors (1)
Lead Sponsor Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

References & Publications (4)

Costa F, Hagan JE, Calcagno J, Kane M, Torgerson P, Martinez-Silveira MS, Stein C, Abela-Ridder B, Ko AI. Global Morbidity and Mortality of Leptospirosis: A Systematic Review. PLoS Negl Trop Dis. 2015 Sep 17;9(9):e0003898. doi: 10.1371/journal.pntd.0003898. eCollection 2015. Review. — View Citation

Delmas B, Jabot J, Chanareille P, Ferdynus C, Allyn J, Allou N, Raffray L, Gaüzere BA, Martinet O, Vandroux D. Leptospirosis in ICU: A Retrospective Study of 134 Consecutive Admissions. Crit Care Med. 2018 Jan;46(1):93-99. doi: 10.1097/CCM.0000000000002825. — View Citation

Haake DA, Levett PN. Leptospirosis in humans. Curr Top Microbiol Immunol. 2015;387:65-97. doi: 10.1007/978-3-662-45059-8_5. Review. — View Citation

Picardeau M. Virulence of the zoonotic agent of leptospirosis: still terra incognita? Nat Rev Microbiol. 2017 May;15(5):297-307. doi: 10.1038/nrmicro.2017.5. Epub 2017 Mar 6. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Mortality at ICU discharge Mortality was evaluated at ICU discharge ICU discharge (usually 5 days)
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