Seroprevalence of Leptospirosis in Val Müstair, Switzerland

NCT05300425 | Completed

• 1 other identifier: 2021-02409; am22Osthoff
• Study Type: observational
• Target: 258
• Locations: 1 country
• Sites: 2

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.

Conditions

Leptospirosis; Hepatitis E Virus Infection; Tularemia

Keywords

seroprevalence; Val Müstair Graubünden; Switzerland

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (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)

Interventions

Blood sample collection OTHER

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 OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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)

You may not qualify if:

• Inability to give consent
• Inability to follow procedures
• Acute infections/inflammatory disease

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Cantonal Hospital of St. Gallen: collaborator

Study Sites (2)

University Hospital Basel, Division of Internal Medicine

Basel, 4031, Switzerland

Location

Center da sanda Val Muestair

Val Müstair, 7536, Switzerland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be stored at -20°C in a dedicated freezer, situated at the Hospital of Val Müstair and will be transferred to a dedicated at -80°C with limited access at the University Hospital Basel after recruitment is complete. If appropriate consent is granted, the samples not used in the study will be biobanked and may be used in future studies.

MeSH Terms

Conditions

Leptospirosis; Hepatitis E; Tularemia

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Hepatitis, Viral, Human; Virus Diseases; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Tick-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Michael Osthoff, PD Dr. med.

  University Hospital Basel, Division of Internal Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: March 29, 2022
• Study Start: March 3, 2022
• Primary Completion: November 15, 2024
• Study Completion: November 15, 2024
• Last Updated: December 13, 2024

Record last verified: 2024-12

Locations

CH (2)