Severe Leptospirosis in Non-tropical Areas

Completed

• Conditions: Epidemiology; Leptospirosis; Alveolar Hemorrhage; Intensive Care Unit

• Registration Number: NCT03912506
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2017-05-07
• Primary Completion: 2018-07-09
• Study Completion: 2018-07-09
• Study First Submitted: 2019-04-09
• Study First Submitted QC: 2019-04-09
• Study First Posted: 2019-04-11
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-14
• Last Update Posted: 2019-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

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

Exclusion Criteria

• No specific exclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality at ICU discharge	ICU discharge (usually 5 days)	Mortality was evaluated at ICU discharge

Trial Locations

Locations (36)

Hopital Saint Louis; 🇫🇷 La Rochelle, France

CH Vannes; 🇫🇷 Vannes, France

CHU Amiens-Picardie; 🇫🇷 Amiens, France

CH Angoulème; 🇫🇷 Angoulême, France

CHRU de Nancy; 🇫🇷 Nancy, France

CHU Angers; 🇫🇷 Angers, France

CH Avignon; 🇫🇷 Avignon, France

CH Annecy; 🇫🇷 Annecy, France

CHU Besançon; 🇫🇷 Besançon, France

hopital saint Leon, CH de la Cote Basque; 🇫🇷 Bayonne, France

CH Fleyriat; 🇫🇷 Bourg-en-Bresse, France

CHU de Caen; 🇫🇷 Caen, France

CH Cahors; 🇫🇷 Cahors, France

CHD de la Vendée; 🇫🇷 La Roche-sur-Yon, France

CH Le Mans; 🇫🇷 Le Mans, France

CH Chartres; 🇫🇷 Chartres, France

CH Cholet; 🇫🇷 Cholet, France

CHU de Lille; 🇫🇷 Lille, France

CHU Cochin APHP; 🇫🇷 Paris, France

GHR MSA; 🇫🇷 Mulhouse, France

Hopital Edouard Herriot, Hospices civils de Lyon; 🇫🇷 Lyon, France

CH Lens; 🇫🇷 Lens, France

CH Niort; 🇫🇷 Niort, France

CHU Saint Louis, APHP; 🇫🇷 Paris, France

CHU Bicetre APHP; 🇫🇷 Paris, France

CHU Henri Mondor; 🇫🇷 Paris, France

CH Valenciennes; 🇫🇷 Valenciennes, France

CH Périgueux; 🇫🇷 Périgueux, France

CH René-Dubost; 🇫🇷 Pontoise, France

CHU Rennes; 🇫🇷 Rennes, France

CH Saint Malo; 🇫🇷 Saint-Malo, France

CH Saint Nazaire; 🇫🇷 Saint-Nazaire, France

CHU Rouen; 🇫🇷 Rouen, France

CH Saint Brieuc; 🇫🇷 Saint-Brieuc, France

CHRU Bretonneau; 🇫🇷 Tours, France

Hopital André Mignot; 🇫🇷 Versailles, France