Severe Leptospirosis in Non-tropical Areas (LEPTOREA)

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

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.

Study Overview

• Status: Completed
• Conditions: Intensive Care Unit; Epidemiology; Leptospirosis; 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.

• Study Type: Observational
• Enrollment (Actual): 160

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• No specific exclusion criteria

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality at ICU discharge	Mortality was evaluated at ICU discharge	ICU discharge (usually 5 days)

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Study Director: Jean Reignier, MD, PhD, Nantes University Hospital

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2017
• Primary Completion (Actual): July 9, 2018
• Study Completion (Actual): July 9, 2018

Study Registration Dates

• First Submitted: April 9, 2019
• First Submitted That Met QC Criteria: April 9, 2019
• First Posted (Actual): April 11, 2019

Study Record Updates

• Last Update Posted (Actual): May 16, 2019
• Last Update Submitted That Met QC Criteria: May 14, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Spirochaetales Infections; Hemorrhage; Leptospirosis; Weil Disease
• Other Study ID Numbers: LEPTOREA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No