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Active, Not Recruiting

NCT Number: NCT05138055

The NOrwegian Tick-borne Encephalitis Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sykehuset Telemark HF, Skien, Telemark, Norway

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

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

    Time frame: 4 years

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

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

    Time frame: 4 years

    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.

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

    Time frame: 5 years

    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.

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

    Time frame: 5 years

    FS-36 and BRIEF

Sponsors and collaborators

Lead sponsor

Sykehuset Telemark

Other Gov

Collaborators

  • Norwegian Institute of Public Health
  • Oslo University Hospital
  • Sorlandet Hospital HF
  • Sykehuset i Vestfold HF

Registry information

Official study title

The NOrwegian Tick-borne Encephalitis Study - NOTES: An Observational Study on Clinical Features, Long-term Outcomes and Immune Characteristics

Acronym: NOTES

Important dates

Study start
2020
Primary completion
2023
Study completion
2027
First posted
Nov 30, 2021
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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