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LeptospirosisLEPTOREANCT03912506

Severe Leptospirosis in Non-tropical Areas

An observational study of Leptospirosis and Intensive Care Unit, run by Nantes University Hospital at 36 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Leptospirosis, Intensive Care Unit, Epidemiology
How many people
160 participants
Where
36 sitesFrance
Study dates
7 May 2017to 9 Jul 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • No specific exclusion criteria

Trial locations and contacts

36 sites in 1 country.

36 sites in 1 country

France36 sites

  • CHU Amiens-Picardie

    Amiens

  • CHU Angers

    Angers

  • CH Angoulème

    Angoulême

  • CH Annecy

    Annecy

  • CH Avignon

    Avignon

  • hopital saint Leon, CH de la Cote Basque

    Bayonne

  • CHU Besançon

    Besançon

  • CH Fleyriat

    Bourg-en-Bresse

  • CHU de Caen

    Caen

  • CH Cahors

    Cahors

  • CH Chartres

    Chartres

  • CH Cholet

    Cholet

  • CHD de la Vendée

    La Roche-sur-Yon

  • Hopital Saint Louis

    La Rochelle

  • CH Le Mans

    Le Mans

  • CH Lens

    Lens

  • CHU de Lille

    Lille

  • Hopital Edouard Herriot, Hospices civils de Lyon

    Lyon

  • GHR MSA

    Mulhouse

  • CHRU de Nancy

    Nancy

  • CH Niort

    Niort

  • CHU Bicetre APHP

    Paris

  • CHU Cochin APHP

    Paris

  • CHU Henri Mondor

    Paris

  • CHU Saint Louis, APHP

    Paris

  • CH Périgueux

    Périgueux

  • CH René-Dubost

    Pontoise

  • CHU Rennes

    Rennes

  • CHU Rouen

    Rouen

  • CH Saint Brieuc

    Saint-Brieuc

  • CH Saint Nazaire

    Saint-Nazaire

  • CH Saint Malo

    St-Malo

  • CHRU Bretonneau

    Tours

  • CH Valenciennes

    Valenciennes

  • CH Vannes

    Vannes

  • Hopital André Mignot

    Versailles

Other trials in France

About this study

Official title: 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.

Read the 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.

Medical subject headings
Leptospirosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03912506
Study groupRoleWhat they receive
Patient admitted in the ICU for leptospirosisPatient admitted in the ICU for leptospirosis None intervention was performed according to retrospective design

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality at ICU discharge

    Mortality was evaluated at ICU discharge

    Measured: ICU discharge (usually 5 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2019
  2. Study start7 May 2017
  3. Primary completion9 Jul 2018
  4. Study completion9 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03912506
Sponsor's protocol ID
LEPTOREA
Acronym
LEPTOREA
Status last verified
May 2019
First submitted
9 Apr 2019
Last updated
16 May 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 25388133

  • 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.

    PubMed 28260786

  • 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.

    PubMed 29116996

  • 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.

    PubMed 26379143

Questions about this trial

What is this clinical trial studying?

An observational study of Leptospirosis and Intensive Care Unit, run by Nantes University Hospital at 36 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality at ICU discharge (time frame: ICU discharge (usually 5 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03912506, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2019.

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