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Severe Leptospirosis in Non-tropical Areas (LEPTOREA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03912506
Recruitment Status : Completed
First Posted : April 11, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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.


Condition or disease
Leptospirosis Intensive Care Unit Epidemiology Alveolar Hemorrhage

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.

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Study Type : Observational
Actual Enrollment : 160 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Severe Leptospirosis in Non-tropical Areas: a Nationwide, Multicentre, Retrospective Study in French ICUs
Actual Study Start Date : May 7, 2017
Actual Primary Completion Date : July 9, 2018
Actual Study Completion Date : July 9, 2018

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Mortality at ICU discharge [ Time Frame: ICU discharge (usually 5 days) ]
    Mortality was evaluated at ICU discharge



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • No specific exclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03912506


Locations
Show Show 36 study locations
Sponsors and Collaborators
Nantes University Hospital
Investigators
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Study Director: Jean Reignier, MD, PhD Nantes University Hospital

Publications:
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03912506    
Other Study ID Numbers: LEPTOREA
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leptospirosis
Weil Disease
Hemorrhage
Pathologic Processes
Gram-Negative Bacterial Infections
Bacterial Infections
Spirochaetales Infections