LeptospirosisNCT05300425
Seroprevalence of Leptospirosis in Val Müstair, Switzerland
An observational study of Leptospirosis and Hepatitis E Virus Infection, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Leptospirosis, Hepatitis E Virus Infection, Tularemia
- What is being tested?
- Blood sample collection and Data collection
- How many people
- 258 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 3 Mar 2022to 15 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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)
Who cannot join
- Inability to give consent
- Inability to follow procedures
- Acute infections/inflammatory disease
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
University Hospital Basel, Division of Internal Medicine
Basel, 4031
Center da sanda Val Muestair
Val Müstair, 7536
About this study
Official title: Leptospirosis, Tularaemia and Hepatitis E in a Rural Mountain Valley in the Alpine Region of Switzerland - A Cross-sectional Exploratory Seroprevalence Study
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
- Being tested
- Blood sample collection, Data collection
- Keywords
- seroprevalence, Val Müstair Graubünden, Switzerland
- Medical subject headings
- Leptospirosis, Hepatitis E, Tularemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample collectionOther
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 collectionOther
Data collection on sociodemographic questions e.g. profession, leisure activities, animal contact
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Change in presence of antibodies against Leptospira spp., Hepatitis E and Francisella tularensis and of all pathogens in risk populations (hunters and farmers)
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start3 Mar 2022
- Primary completion15 Nov 2024
- Study completion15 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeptospirosisStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Cantonal Hospital of St. Gallen
- Responsible party
- Sponsor
- Investigators
- Michael Osthoff, PD Dr. med., Principal investigator, University Hospital Basel, Division of Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05300425
- Sponsor's protocol ID
- 2021-02409; am22Osthoff
- Status last verified
- Dec 2024
- First submitted
- 16 Mar 2022
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leptospirosis, Tularaemia and Hepatitis E in a Rural Mountain Valley in the Alpine Region of Switzerland - A Cross-sectional Exploratory Seroprevalence Study
- ClinicalTrials.gov ID
- NCT05300425
- Acronym / sponsor ID
- 2021-02409; am22Osthoff
- Conditions
- Leptospirosis, Hepatitis E Virus Infection, Tularemia
- Keywords
- seroprevalence, Val Müstair Graubünden, Switzerland
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Cantonal Hospital of St. Gallen
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 29 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- Inability to give consent
- Inability to follow procedures
- Acute infections/inflammatory disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample collectionBlood 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). | Other | – |
| Data collectionData collection on sociodemographic questions e.g. profession, leisure activities, animal contact | Other | – |
Primary outcome
Change in presence of antibodies against Leptospira spp, Francisella tularensis and Hepatitis E
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 against Leptospira spp, Francisella tularensis and Hepatitis E evaluated by serology at two different time points
1 secondary outcome
Change in presence of antibodies 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
Related trials for Leptospirosis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Osthoff, PD Dr. med. principal investigator
University Hospital Basel, Division of Internal Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leptospirosis and Hepatitis E Virus Infection, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in presence of antibodies against Leptospira spp, Francisella tularensis and Hepatitis E (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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.