Leptospirosis Registry Gathers Knowledge on Epidemiology, Clinical Course, Prognostic Factors and Molecular Characteristics for Invasive Leptospirosis Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Leptospirosis Registry - LeptoScope

Conditions
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Leptospirosis

Intervention / Treatment
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* Other: Retrospective data collection of demographics
* Other: Retrospective data collection of underlying diseases
* Other: Retrospective data collection of duration of hospitalization


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Leptospirosis group<br>Patients with cultural, serological, molecular or histological evidence and clinical evidence of invasive leptospirosis disease. | Other: Retrospective data collection of demographics<br>* Retrospective data collection of demographics from patients with leptospirosis and matching control group patients.<br>Other: Retrospective data collection of underlying diseases<br>* Retrospective data collection of underlying diseases from patients with leptospirosis and matching control group patients.<br>Other: Retrospective data collection of duration of hospitalization<br>* Retrospective data collection of duration of hospitalization from patients with leptospirosis and matching control group patients.<br>|
| Control group<br>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) | Other: Retrospective data collection of demographics<br>* Retrospective data collection of demographics from patients with leptospirosis and matching control group patients.<br>Other: Retrospective data collection of underlying diseases<br>* Retrospective data collection of underlying diseases from patients with leptospirosis and matching control group patients.<br>Other: Retrospective data collection of duration of hospitalization<br>* Retrospective data collection of duration of hospitalization from patients with leptospirosis and matching control group patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence | To describe the global incidence of invasive leptospirosis disease | up to 100 weeks | 
| Mortality | To describe global mortality due to invasive leptospirosis disease | up to 100 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resistance development | To describe resistance developments of Leptospirosis spp. | up to 100 weeks | 
| Treatment efficacy of invasive leptospirosis disease in participants with treatment failure | To describe the number of participants with treatment failure | at 90 days from diagnosis | 
| Treatment efficacy of invasive leptospirosis disease in participants with stable disease | To describe the number of participants with stable disease | at 90 days from diagnosis | 
| Treatment efficacy of invasive leptospirosis disease in participants with partial responses | To describe the number of participants with partial responses | at 90 days from diagnosis | 
| Treatment efficacy of invasive leptospirosis disease in participants with complete responses | To describe the number of participants with complete responses | at 90 days from diagnosis | 
| Occurrence of acute kidney injury according to KDIGO I, II, III | To describe the occurrence of acute kidney injury according to KDIGO I, II, III disease | at 90 days from diagnosis | 
| Occurrence of chronic kidney disease | To describe the occurrence of chronic kidney disease | up to 500 weeks | 
| Need for renal replacement therapy | To describe the need for renal replacement therapy approaches | up to 500 weeks |