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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05300425
Other study ID # 2021-02409; am22Osthoff
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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)
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