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NCT Number: NCT03912506

Severe Leptospirosis in Non-tropical Areas

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.

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Key information

Conditions

Leptospirosis Alveolar Hemorrhage Bacterial Infections Bacterial Infections and Mycoses Epidemiology Gram-Negative Bacterial Infections Infections Intensive Care Unit Spirochaetales Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Amiens-Picardie, Amiens, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • No specific exclusion criteria

Treatment and study plan

Primary outcomes

  1. Mortality at ICU discharge

    Time frame: ICU discharge (usually 5 days)

    Mortality was evaluated at ICU discharge

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: LEPTOREA

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 11, 2019
Registry last updated
May 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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