Active — Not RecruitingNot Applicable

The NOrwegian Tick-borne Encephalitis Study

Norway153 participantsStarted 2020-10-01

Plain-language summary

During 2018, 2019, and 2020, the reported TBE-cases have increased markedly in Norway. Surveillance studies conducted by the Norwegian Institute of Public Health demonstrate that cases are associated with tick bites in the coastal areas of the Agder, Buskerud, and Vestfold and Telemark counties There is a urgent need for more knowledge of the consequences of TBE in Norway, in particular the identification of patients at risk of long-term sequela. Hence, the overall objective of this project is to gain more knowledge about the natural course of TBE in Norway, and its impact on long-term health-related quality of life and associated factors. Clinical data, biological sampling and PROMs are collected from TBE-infected patients admitted to three hospitals within the epidemic region in Norway.

Who can participate

Age range

16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patient: The patients diagnosed with acute infection with TBEV at admission.
. Control: same age (plus/minus 4 years), level of education (plus minus 2 years) and the same gender as patient.

Exclusion criteria

. Patient: Patients who turn out to have different diagnose than acute infections with TBEV.
. Control: Previously infection with tick-borne encephalitis virus.
. The patients who were diagnosed with typical symptoms and only TBEV IgM-test must take a blood sample for IgG analyses. If the TBE IgG analysis is negative, the patient will be excluded.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To describe the acute phase clinical and immunological characteristics of TBE in Norway

Timeframe: 4 years

To investigate the impact of TBEV infection on health-related QOL in a one year follow-up study of a Norwegian patient cohort

Timeframe: 4 years

To investigate the impact of TBEV infection on long-term cognitive function in a one year follow-up study of a Norwegian patient cohort

Timeframe: 5 years

To identify biomarkers in the cerebrospinal fluid (CSF) and blood, which serve as predictors for TBE severity and long-term complaints

Timeframe: 5 years

Trial details

NCT IDNCT05138055

SponsorSykehuset Telemark

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2023-12-31

View on ClinicalTrials.gov More Tick-Borne Encephalitis, European trials

Plain-language summary

Who can participate

Age range

16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patient: The patients diagnosed with acute infection with TBEV at admission.
. Control: same age (plus/minus 4 years), level of education (plus minus 2 years) and the same gender as patient.

Exclusion criteria

. Patient: Patients who turn out to have different diagnose than acute infections with TBEV.
. Control: Previously infection with tick-borne encephalitis virus.
. The patients who were diagnosed with typical symptoms and only TBEV IgM-test must take a blood sample for IgG analyses. If the TBE IgG analysis is negative, the patient will be excluded.

What they're measuring

To describe the acute phase clinical and immunological characteristics of TBE in Norway

Timeframe: 4 years

To investigate the impact of TBEV infection on health-related QOL in a one year follow-up study of a Norwegian patient cohort

Timeframe: 4 years

To investigate the impact of TBEV infection on long-term cognitive function in a one year follow-up study of a Norwegian patient cohort

Timeframe: 5 years

To identify biomarkers in the cerebrospinal fluid (CSF) and blood, which serve as predictors for TBE severity and long-term complaints

Timeframe: 5 years