The NOrwegian Tick-borne Encephalitis Study

NCT05138055 | Active Not Recruiting

• 1 other identifier: 96505
• Study Type: observational
• Target: 153
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Tick-Borne Encephalitis, European

Outcome Measures

Primary Outcomes (4)

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

  clinical features and objective findings of the acute phase of the TBE-patients diagnosed with TBE in South-East Norway during 2018-2021

  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

  A prospective multicenter study of health-related QOL one year after hospitalization with TBE in South-East Norway from 2019-2022. The self-reported health-related QOL (assessed by SF-36) of the TBE-patients, will be compared with the SF-36 reference values in the Norwegian population.

  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

  A prospective multicenter study of self-reported cognitive function by BRIEF, FSS, HADS and EMQ, one year after hospitalization with TBE in South-East Norway from 2019-2022. The cognitive function, measured by PROMS, will be compared with PROMS from an included reference group from the patient's social environment.

  5 years

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

  FS-36 and BRIEF

  5 years

Interventions

No intervention OTHER

No intervention

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population in substudy 1. Patients \> 16 years old diagnosed with acute infection caused by TBEV. The hospitals involved are Telemark and Vestfold. Study population in substudy 2. Patients \> 16 years old diagnosed with acute infection caused by TBEV. The hospitals involved are Telemark, Vestfold and Sørlandet.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sykehuset Telemark: lead
• Sykehuset i Vestfold HF: collaborator
• Norwegian Institute of Public Health: collaborator
• Sorlandet Hospital HF: collaborator
• Oslo University Hospital: collaborator

Study Sites (3)

Sykehuset Telemark HF

Skien, Telemark, 3710, Norway

Location

Sykehuset Sørlandet HF

Arendal, Norway

Location

Sykehuset i Vestfold

Tønsberg, Norway

Location

Related Publications (1)

• Veje M, Nolskog P, Petzold M, Bergstrom T, Linden T, Peker Y, Studahl M. Tick-Borne Encephalitis sequelae at long-term follow-up: a self-reported case-control study. Acta Neurol Scand. 2016 Dec;134(6):434-441. doi: 10.1111/ane.12561. Epub 2016 Jan 26.

  PMID: 26810689 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and csf

MeSH Terms

Conditions

Encephalitis, Tick-Borne

Condition Hierarchy (Ancestors)

Encephalitis, Arbovirus; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infections; Infectious Encephalitis; Arbovirus Infections; Vector Borne Diseases; Tick-Borne Diseases; Virus Diseases; RNA Virus Infections; Flavivirus Infections; Flaviviridae Infections; Encephalitis; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Study Officials

• Hege Kersten, PhD

  Study director

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: November 30, 2021
• Study Start: October 1, 2020
• Primary Completion: December 31, 2023
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (3)