Seroprevalence of Leptospirosis in Val Müstair, Switzerland

Leptospirosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05300425
• Other study ID #: 2021-02409; am22Osthoff
• Status: Recruiting
• Start date: March 3, 2022
• Est. completion date: January 2025

Study information

• Verified date: October 2023
• Source: University Hospital, Basel, Switzerland
• Contact: Michael Osthoff, PD Dr. med.
• Phone: +41 61 328 68 28
• Email: michael.osthoff[@]usb.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis E
• Hepatitis E Virus Infection
• Leptospirosis
• Tularemia

Intervention

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

Locations

Country	Name	City	State
Switzerland	University Hospital Basel, Division of Internal Medicine	Basel
Switzerland	Center da sanda Val Muestair	Val Müstair

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Kantonsspital St. Gallen, St. Gallen, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)