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Completed

NCT Number: NCT05300425

Seroprevalence of Leptospirosis in Val Müstair, Switzerland

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.

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Key information

Conditions

Leptospirosis Bacterial Infections Bacterial Infections and Mycoses Digestive System Diseases Gram-Negative Bacterial Infections Hepatitis Hepatitis E Hepatitis E Virus Infection Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Spirochaetales Infections Tick-Borne Diseases Tularemia Vector Borne Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Basel, Division of Internal Medicine, Basel, Switzerland

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood Sample Collection

Other

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).

Data Collection

Other

Data collection on sociodemographic questions e.g. profession, leisure activities, animal contact

Primary outcomes

  1. Change in presence of antibodies against Leptospira spp, Francisella tularensis and Hepatitis E

    Time frame: 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)

    Change in presence of antibodies against Leptospira spp, Francisella tularensis and Hepatitis E evaluated by serology at two different time points

Secondary outcomes

  1. Change in presence of antibodies in risk populations (hunters and farmers)

    Time frame: 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)

    Change in presence of antibodies against Leptospira spp., Hepatitis E and Francisella tularensis and of all pathogens in risk populations (hunters and farmers)

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Cantonal Hospital of St. Gallen

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 29, 2022
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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