The NOrwegian Tick-borne Encephalitis Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

153 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-01

Study Completion Date

2027-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Phenomenon of "Chronic Lyme"; an Observational Study

NCT01151150

Chronic Lyme Borreliosis

COMPLETED

Effect of Intravenous Ceftriaxone and Oral Doxycycline for Lyme Neuroborreliosis

NCT00138801

Lyme Neuroborreliosis

COMPLETED PHASE3

Tick-borne Encephalitis Virus Research in Limousin

NCT05941546

Tick-borne Encephalitis

COMPLETED

SWEtick - a Prospective Multicenter Study of Tick-borne Diseases in Sweden

NCT06781008

Tick-Borne Diseases

RECRUITING

Comparing 3 Antibiotic Regimes for Erythema Migrans in General Practice

NCT01368341

Erythema Migrans Erythema Chronicum Migrans Borreliosis +2 more

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This project is designed as a multicenter study divided into four sub-studies:

Substudy 1: A retrospective descriptive study of the clinical features and objective findings of the acute phase of the TBE-patients diagnosed with TBE in South-East Norway during 2018, 2019 and 2020.

Substudy 2: A prospective multicenter study of health related QOL one year after hospitalization with TBE in South-East Norway from 2019 - 2023. The self-reported health-related QOL (assesedby SF-36) of the TBE-patients will be compared with the SF-36 reference values in the Norwegian population.

Substudy 3: A prospective multicenter study of self-reported cognitive function one year after hospitalization with TBE in South-East Norway from 2019- 2023. The cognitive function, measured by PROMS, will be compared with PROMS from an included reference group from the patient's social environment.

Substudy 4: Analyses of biological samples collected at baseline, 3 months and 12 months after hospitalization for TBE in patients included in substudy 2 and 3. These analyses will be conducted to gain more knowledge of the pathogenesis of TBE infection and in particular, which molecular pathways and biomarkers that characterize the TBE infected patients who are hospitalized in Norway. Analyses to identify associations between the acute inflammatory response and long-term outcome will be performed.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tick-Borne Encephalitis, European

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

No intervention

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

1. Patient: Patients who turn out to have different diagnose than acute infections with TBEV.
2. Control: Previously infection with tick-borne encephalitis virus.
3. 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.

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No