Seroprevalence of Leptospirosis in Val Müstair, Switzerland

Study Overview
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Brief Summary
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Human leptospirosis is a zoonotic disease caused by bacteria of the genus Leptospira. Due to its frequent inapparent course or mild severity with unspecific symptoms and limited availability of diagnostic laboratories the incidence of leptospirosis is likely to be underestimated. The hospital of Val Müstair is the major healthcare provider of a rural mountain valley in the canton of Graubünden/ Switzerland with approximately 1500 inhabitants. A relevant prevalence of Leptospira spp. antibodies in the population of the Val Müstair due to its geographic and social risk profile for Leptospira infection, namely the close contact of the population to both livestock and wildlife in agriculture and hunting is estimated. The aim of this study is to analyze the burden of this disease in order to evaluate the need of preventive measures. In addition, seroepidemiological data for the Hepatitis E virus (HEV) and for tularemia will be collected.

Official Title
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Leptospirosis, Tularaemia and Hepatitis E in a Rural Mountain Valley in the Alpine Region of Switzerland - A Cross-sectional Exploratory Seroprevalence Study

Conditions
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Leptospirosis, Hepatitis E Virus Infection, Tularemia

Intervention / Treatment
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* Other: Blood sample collection
* Other: Data collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent as documented by signature Aged 18 years or older Living for at least one year mainly (>6 months per year) in Val Müstair (including Taufers and Rifair, Italy) Exclusion Criteria: Inability to give consent Inability to follow procedures Acute infections/inflammatory disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Blood sample collection|Blood sample collection (at baseline and approximately two years after baseline). Enzyme-linked immunosorbent assays will be used to screen for IgG and IgM antibodies directed against the three pathogens (Leptospirosis, Tularemia, Hepatitis E).|
|Other: Data collection|Data collection on sociodemographic questions e.g. profession, leisure activities, animal contact|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in presence of antibodies against Leptospira spp, Francisella tularensis and Hepatitis E | Change in presence of antibodies against Leptospira spp, Francisella tularensis and Hepatitis E evaluated by serology at two different time points | at baseline and approximately two years after baseline (project duration for each patient is one day or two days respectively, if they agree for another blood sampling in two years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in presence of antibodies in risk populations (hunters and farmers) | Change in presence of antibodies against Leptospira spp., Hepatitis E and Francisella tularensis and of all pathogens in risk populations (hunters and farmers) | at baseline and approximately two years after baseline (project duration for each patient is one day or two days respectively, if they agree for another blood sampling in two years) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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seroprevalence, Val Müstair Graubünden, Switzerland