NCT03912506

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2017

Geographic Reach
1 country

36 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 7, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 11, 2019

Completed
Last Updated

May 16, 2019

Status Verified

May 1, 2019

Enrollment Period

1.2 years

First QC Date

April 9, 2019

Last Update Submit

May 14, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mortality at ICU discharge

    Mortality was evaluated at ICU discharge

    ICU discharge (usually 5 days)

Study Arms (1)

Patient admitted in the ICU for leptospirosis

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (36)

CHU Amiens-Picardie

Amiens, France

Location

CHU Angers

Angers, France

Location

CH Angoulème

Angoulême, France

Location

CH Annecy

Annecy, France

Location

CH Avignon

Avignon, France

Location

hopital saint Leon, CH de la Cote Basque

Bayonne, France

Location

CHU Besançon

Besançon, France

Location

CH Fleyriat

Bourg-en-Bresse, France

Location

CHU de Caen

Caen, France

Location

CH Cahors

Cahors, France

Location

CH Chartres

Chartres, France

Location

CH Cholet

Cholet, France

Location

CHD de la Vendée

La Roche-sur-Yon, France

Location

Hopital Saint Louis

La Rochelle, France

Location

CH Le Mans

Le Mans, France

Location

CH Lens

Lens, France

Location

CHU de Lille

Lille, France

Location

Hopital Edouard Herriot, Hospices civils de Lyon

Lyon, France

Location

GHR MSA

Mulhouse, France

Location

CHRU de Nancy

Nancy, France

Location

CH Niort

Niort, France

Location

CHU Bicetre APHP

Paris, France

Location

CHU Cochin APHP

Paris, France

Location

CHU Henri Mondor

Paris, France

Location

CHU Saint Louis, APHP

Paris, France

Location

CH Périgueux

Périgueux, France

Location

CH René-Dubost

Pontoise, France

Location

CHU Rennes

Rennes, France

Location

CHU Rouen

Rouen, France

Location

CH Saint Brieuc

Saint-Brieuc, France

Location

CH Saint Nazaire

Saint-Nazaire, France

Location

CH Saint Malo

St-Malo, France

Location

CHRU Bretonneau

Tours, France

Location

CH Valenciennes

Valenciennes, France

Location

CH Vannes

Vannes, France

Location

Hopital André Mignot

Versailles, France

Location

Related Publications (4)

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

    PMID: 25388133BACKGROUND
  • 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.

    PMID: 28260786BACKGROUND
  • 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.

    PMID: 29116996BACKGROUND
  • 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.

    PMID: 26379143BACKGROUND

MeSH Terms

Conditions

Leptospirosis

Condition Hierarchy (Ancestors)

Spirochaetales InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Jean Reignier, MD, PhD

    Nantes University Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2019

First Posted

April 11, 2019

Study Start

May 7, 2017

Primary Completion

July 9, 2018

Study Completion

July 9, 2018

Last Updated

May 16, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations