Seroprevalence of Leptospirosis in Val Müstair, Switzerland

Completed

• Conditions: Leptospirosis; Tularemia; Hepatitis E Virus Infection

• Registration Number: NCT05300425
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-03
• Study First Submitted: 2022-03-16
• Study First Submitted QC: 2022-03-18
• Study First Posted: 2022-03-29
• Primary Completion: 2024-11-15
• Study Completion: 2024-11-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 258

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (2)

University Hospital Basel, Division of Internal Medicine; 🇨🇭 Basel, Switzerland

Center da sanda Val Muestair; 🇨🇭 Val Müstair, Switzerland