Seroprevalence of Leptospirosis in Val Müstair, Switzerland

December 12, 2024 updated by: University Hospital, Basel, Switzerland

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

258

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • University Hospital Basel, Division of Internal Medicine
      • Val Müstair, Switzerland, 7536
        • Center da sanda Val Muestair

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

250 participants presenting to the medical office of the Hospital of Val Müstair will be included. There will be a consecutive ongoing recruitment through the medical staff in daily clinical practice and during regular blood donation days. Risk populations (hunters and farmes, national park rangers) will be directly addressed (newspaper announcement and via associations).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Collaborators

Kantonsspital St. Gallen, St. Gallen, Switzerland

Investigators

  • Principal Investigator: Michael Osthoff, PD Dr. med., University Hospital Basel, Division of Internal Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2022

Primary Completion (Actual)

November 15, 2024

Study Completion (Actual)

November 15, 2024

Study Registration Dates

First Submitted

March 16, 2022

First Submitted That Met QC Criteria

March 18, 2022

First Posted (Actual)

March 29, 2022

Study Record Updates

Last Update Posted (Estimated)

December 13, 2024

Last Update Submitted That Met QC Criteria

December 12, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-02409; am22Osthoff

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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