Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2020-03-04
2030-12-31
Brief Summary
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Detailed Description
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Incidence of invasive leptospirosis disease causing acute kidney injury, acute respiratory distress syndrome (ARDS), myocarditis, hepatic dysfunction, hemorrhage and multi-organ failure, is globally increasing and there have been frequent outbreak situation throughout the world. In Europe, invasive leptospirosis disease is less common than in the tropical and subtropical countries, however due to climate change incidence is rising, and there are worry-some trends concerning chancing species distribution and multiple outbreak situations throughout central Europe. Current treatment approaches consist of antibiotic therapies. Additionally, salvage supportive treatment approaches of critical ill patients are common in invasive leptospirosis disease requiring dialysis, hemodynamic support, mechanical ventilation or even extracorporeal membrane oxygenation (ECMO). Furthermore, invasive leptospirosis disease is associated with the development of chronic kidney disease.
Due to increasing outbreak situations and globally chances in species distributions, a worldwide surveillance in epidemiology and species distribution is urgently needed. Additionally, the examination of attributable mortality and costs analysis of invasive leptospirosis disease will need to be studied on a multinational basis and therefore LeptoScope will particularly use a matched case control design.
The objective of the Leptospirosis Registry - LeptoScope is to overcome the lack knowledge on epidemiology, clinical course, prognostic factors and molecular characteristics for invasive leptospirosis disease. Additionally, LeptoScope serves as a platform for monitoring complications of invasive leptospirosis disease and outbreak situations.
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Leptospirosis group
Patients with cultural, serological, molecular or histological evidence and clinical evidence of invasive leptospirosis disease.
Retrospective data collection of demographics
Retrospective data collection of demographics from patients with leptospirosis and matching control group patients.
Retrospective data collection of underlying diseases
Retrospective data collection of underlying diseases from patients with leptospirosis and matching control group patients.
Retrospective data collection of duration of hospitalization
Retrospective data collection of duration of hospitalization from patients with leptospirosis and matching control group patients.
Control group
Controls will be included at the same hospitals that conduced cases based on matching of demographics, underlying diseases and duration of hospitalization (i.e. one control per case, both in the same hospital)
Retrospective data collection of demographics
Retrospective data collection of demographics from patients with leptospirosis and matching control group patients.
Retrospective data collection of underlying diseases
Retrospective data collection of underlying diseases from patients with leptospirosis and matching control group patients.
Retrospective data collection of duration of hospitalization
Retrospective data collection of duration of hospitalization from patients with leptospirosis and matching control group patients.
Interventions
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Retrospective data collection of demographics
Retrospective data collection of demographics from patients with leptospirosis and matching control group patients.
Retrospective data collection of underlying diseases
Retrospective data collection of underlying diseases from patients with leptospirosis and matching control group patients.
Retrospective data collection of duration of hospitalization
Retrospective data collection of duration of hospitalization from patients with leptospirosis and matching control group patients.
Eligibility Criteria
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Inclusion Criteria
* Clinical signs of disseminated leptospirosis disease without cultural, serological, molecular or histological evidence
* Case controls: Matching procedures for controls: Particularly, case controls will be included at the same hospitals that conduced cases based on matching of demographics, underlying diseases and duration of hospitalization (i.e. one control per case, both in the same hospital).
Exclusion Criteria
* Cultural, serological, molecular or histological evidence without dissemination
ALL
No
Sponsors
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University of Cologne
OTHER
Responsible Party
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Volker Burst
Principal Investigator
Principal Investigators
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Volker Burst, MD
Role: STUDY_CHAIR
University Hospital of Cologne
Felix Köhler, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Cologne
Locations
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University Hospital of Cologne
Cologne, North Rhine-Westphalia, Germany
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Related information
Other Identifiers
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Version 1.0
Identifier Type: -
Identifier Source: org_study_id