Leptospirosis Registry - LeptoScope
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Retrospective data collection of demographics, Retrospective data collection of underlying diseases, Retrospective data collection of duration of hospitalization.
- Who it may be relevant to
- Registry conditions: Leptospirosis. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Leptospirosis is a worldwide zoonotic diseases caused by pathogenic Leptospira spp. Human are accidental hosts, who acquired infections after exposition to animal urine, contaminated water or soil, infected tissue. 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. Due to increasing outbreak situations and globally chances in species distributions, a worldwide surveillance in epidemiology and species distribution is urgently needed. 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.
Detailed description
Leptospirosis is a worldwide zoonotic diseases caused by pathogenic Leptospira spp. Human are accidental hosts, who acquired infections after exposition to animal urine, contaminated water or soil, infected tissue. During bacteremia, Leptospira spp. may lead to invasive, deep-seated leptospirosis with infection of kidney, liver, heart and the central nervous system. Although cleaned from blood and most tissue by immune response, Leptospira spp. can persists and multiply in the tubuli of kidneys.
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.
Interventions
- Other Retrospective data collection of demographics
Retrospective data collection of demographics from patients with leptospirosis and matching control group patients. - Other Retrospective data collection of underlying diseases
Retrospective data collection of underlying diseases from patients with leptospirosis and matching control group patients. - Other Retrospective data collection of duration of hospitalization
Retrospective data collection of duration of hospitalization from patients with leptospirosis and matching control group patients.
Primary outcome measures
- Incidence [Time frame: up to 100 weeks]
- Mortality [Time frame: up to 100 weeks]
Secondary outcome measures (8)
- Resistance development [Time frame: up to 100 weeks]
- Treatment efficacy of invasive leptospirosis disease in participants with treatment failure [Time frame: at 90 days from diagnosis]
- Treatment efficacy of invasive leptospirosis disease in participants with stable disease [Time frame: at 90 days from diagnosis]
- Treatment efficacy of invasive leptospirosis disease in participants with partial responses [Time frame: at 90 days from diagnosis]
- Treatment efficacy of invasive leptospirosis disease in participants with complete responses [Time frame: at 90 days from diagnosis]
- Occurrence of acute kidney injury according to KDIGO I, II, III [Time frame: at 90 days from diagnosis]
- Occurrence of chronic kidney disease [Time frame: up to 500 weeks]
- Need for renal replacement therapy [Time frame: up to 500 weeks]
Eligibility criteria
Inclusion criteria
- Cultural, serological, molecular or histological evidence of invasive leptospirosis diseases
- 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
- Colonization or other non-invasive infection
- Cultural, serological, molecular or histological evidence without dissemination
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Germany · 1 center
- University Hospital of Cologne — Cologne
Identifiers
NCT: NCT04288674 · Version 1.0