Seroprevalence of Leptospirosis in Val Müstair, Switzerland

Sponsor
University Hospital, Basel, Switzerland (Other)
Overall Status
Recruiting
CT.gov ID
NCT05300425
Collaborator
Kantonsspital St. Gallen, St. Gallen, Switzerland (Other)
250
2
34
125
3.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Blood sample collection
  • Other: Data collection

Study Design

Study Type:
Observational
Anticipated Enrollment :
250 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Leptospirosis, Tularaemia and Hepatitis E in a Rural Mountain Valley in the Alpine Region of Switzerland - A Cross-sectional Exploratory Seroprevalence Study
Actual Study Start Date :
Mar 3, 2022
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Jan 1, 2025

Outcome Measures

Primary Outcome Measures

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

  1. Change in presence of antibodies 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)]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Basel, Division of Internal Medicine Basel Switzerland 4031
2 Center da sanda Val Muestair Val Müstair Switzerland 7536

Sponsors and Collaborators

  • University Hospital, Basel, Switzerland
  • Kantonsspital St. Gallen, St. Gallen, Switzerland

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT05300425
Other Study ID Numbers:
  • 2021-02409; am22Osthoff
First Posted:
Mar 29, 2022
Last Update Posted:
Mar 29, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Basel, Switzerland
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 29, 2022