Clinical trial NCT03912506: Severe Leptospirosis in Non-tropical Areas
Official title: Severe Leptospirosis in Non-tropical Areas: a Nationwide, Multicentre, Retrospective Study in French ICUs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leptospirosis
Intensive Care Unit
Epidemiology
Alveolar Hemorrhage
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2019-04-11
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted in participating ICUs between January 2012 and September 2016 and diagnosed having leptospirosis were included in the study. Patients were identified by searching code A27 in the hospitals databases for International Statistical Classification of Diseases and Related Health Problems, 10th revision

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Patient admitted in ICU
* Leptospirosis confirmed with one laboratory test (MAT, ELISA, PCR, direct examination)

Exclusion Criteria:

* No specific exclusion criteria

Primary outcomes:
measure: Mortality at ICU discharge
timeFrame: ICU discharge (usually 5 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens-Picardie
city: Angers
country: France
facility: CHU Angers
city: Angoulême
country: France
facility: CH Angoulème
city: Annecy
country: France
facility: CH Annecy
city: Avignon
country: France
facility: CH Avignon
city: Bayonne
country: France
facility: hopital saint Leon, CH de la Cote Basque
city: Besançon
country: France
facility: CHU Besançon
city: Bourg-en-Bresse
country: France
facility: CH Fleyriat
city: Caen
country: France
facility: CHU de Caen
city: Cahors
country: France
facility: CH Cahors
city: Chartres
country: France
facility: CH Chartres
city: Cholet
country: France
facility: CH Cholet
city: La Roche-sur-Yon
country: France
facility: CHD de la Vendée
city: La Rochelle
country: France
facility: Hopital Saint Louis
city: Le Mans
country: France
facility: CH Le Mans
city: Lens
country: France
facility: CH Lens
city: Lille
country: France
facility: CHU de Lille
city: Lyon
country: France
facility: Hopital Edouard Herriot, Hospices civils de Lyon
city: Mulhouse
country: France
facility: GHR MSA
city: Nancy
country: France
facility: CHRU de Nancy
city: Niort
country: France
facility: CH Niort
city: Paris
country: France
facility: CHU Bicetre APHP
city: Paris
country: France
facility: CHU Cochin APHP
city: Paris
country: France
facility: CHU Henri Mondor
city: Paris
country: France
facility: CHU Saint Louis, APHP
city: Pontoise
country: France
facility: CH René-Dubost
city: Périgueux
country: France
facility: CH Périgueux
city: Rennes
country: France
facility: CHU Rennes
city: Rouen
country: France
facility: CHU Rouen
city: Saint-Brieuc
country: France
facility: CH Saint Brieuc
city: Saint-Malo
country: France
facility: CH Saint Malo
city: Saint-Nazaire
country: France
facility: CH Saint Nazaire
city: Tours
country: France
facility: CHRU Bretonneau
city: Valenciennes
country: France
facility: CH Valenciennes
city: Vannes
country: France
facility: CH Vannes
city: Versailles
country: France
facility: Hopital André Mignot
Study officials:
affiliation: Nantes University Hospital
name: Jean Reignier, MD, PhD
role: STUDY_DIRECTOR
References:
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.
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.
citation: Delmas B, Jabot J, Chanareille P, Ferdynus C, Allyn J, Allou N, Raffray L, Gauzere 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.
citation: 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.