Clinical trial NCT05300425: Seroprevalence of Leptospirosis in Val Müstair, Switzerland
Official title: Leptospirosis, Tularaemia and Hepatitis E in a Rural Mountain Valley in the Alpine Region of Switzerland - A Cross-sectional Exploratory Seroprevalence Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leptospirosis
Hepatitis E Virus Infection
Tularemia
Keywords: seroprevalence
Val Müstair Graubünden
Switzerland
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Kantonsspital St. Gallen, St. Gallen, Switzerland
First posted: 2022-03-29
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in presence of antibodies against Leptospira spp, Francisella tularensis and Hepatitis E
timeFrame: 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 outcomes:
measure: Change in presence of antibodies in risk populations (hunters and farmers)
timeFrame: 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)
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel, Division of Internal Medicine
city: Val Müstair
country: Switzerland
facility: Center da sanda Val Muestair
Study officials:
affiliation: University Hospital Basel, Division of Internal Medicine
name: Michael Osthoff, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: