Severe Leptospirosis in Non-tropical Areas

NCT ID: NCT03912506

Last Updated: 2019-05-16

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-07

Study Completion Date

2018-07-09

Brief Summary

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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

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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.

Conditions

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Leptospirosis Intensive Care Unit Epidemiology Alveolar Hemorrhage

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patient admitted in the ICU for leptospirosis

Patient admitted in the ICU for leptospirosis None intervention was performed according to retrospective design

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean Reignier, MD, PhD

Role: STUDY_DIRECTOR

Nantes University Hospital

Locations

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CHU Amiens-Picardie

Amiens, , France

Site Status

CHU Angers

Angers, , France

Site Status

CH Angoulème

Angoulême, , France

Site Status

CH Annecy

Annecy, , France

Site Status

CH Avignon

Avignon, , France

Site Status

hopital saint Leon, CH de la Cote Basque

Bayonne, , France

Site Status

CHU Besançon

Besançon, , France

Site Status

CH Fleyriat

Bourg-en-Bresse, , France

Site Status

CHU de Caen

Caen, , France

Site Status

CH Cahors

Cahors, , France

Site Status

CH Chartres

Chartres, , France

Site Status

CH Cholet

Cholet, , France

Site Status

CHD de la Vendée

La Roche-sur-Yon, , France

Site Status

Hopital Saint Louis

La Rochelle, , France

Site Status

CH Le Mans

Le Mans, , France

Site Status

CH Lens

Lens, , France

Site Status

CHU de Lille

Lille, , France

Site Status

Hopital Edouard Herriot, Hospices civils de Lyon

Lyon, , France

Site Status

GHR MSA

Mulhouse, , France

Site Status

CHRU de Nancy

Nancy, , France

Site Status

CH Niort

Niort, , France

Site Status

CHU Bicetre APHP

Paris, , France

Site Status

CHU Cochin APHP

Paris, , France

Site Status

CHU Henri Mondor

Paris, , France

Site Status

CHU Saint Louis, APHP

Paris, , France

Site Status

CH Périgueux

Périgueux, , France

Site Status

CH René-Dubost

Pontoise, , France

Site Status

CHU Rennes

Rennes, , France

Site Status

CHU Rouen

Rouen, , France

Site Status

CH Saint Brieuc

Saint-Brieuc, , France

Site Status

CH Saint Nazaire

Saint-Nazaire, , France

Site Status

CH Saint Malo

St-Malo, , France

Site Status

CHRU Bretonneau

Tours, , France

Site Status

CH Valenciennes

Valenciennes, , France

Site Status

CH Vannes

Vannes, , France

Site Status

Hopital André Mignot

Versailles, , France

Site Status

Countries

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France

References

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

Reference Type BACKGROUND
PMID: 25388133 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28260786 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29116996 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26379143 (View on PubMed)

Other Identifiers

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LEPTOREA

Identifier Type: -

Identifier Source: org_study_id

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