An observational study in Leptospirosis, Hepatitis E Virus Infection and Tularemia, sponsored by University Hospital, Basel, Switzerland. Completed at 2 sites in Switzerland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-13.
Sponsored by University Hospital, Basel, Switzerland · Observational
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.
25 studies on the registry are indexed under Leptospirosis; 11 are open to participants now.
This study's enrollment of 258 is above the median of 175 across 11 observational studies indexed under Leptospirosis.
Browse Leptospirosis studies →University Hospital, Basel, Switzerland is the lead sponsor of 990 studies on the registry; 189 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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).
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 on sociodemographic questions e.g. profession, leisure activities, animal contact
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
Time frame: 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 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)
Time frame: 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)
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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University Hospital, Basel, Switzerland →