The Norwegian Tick Born Encephalitis Study

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Brief Title

The Norwegian Tick Born Encephalitis Study

Official Title

The Norwegian Tick Born Encephalitis Study Acute Phase Characteristics and Long-tern Outcomes

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.
    

Detailed Description

      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.
    


Study Type

Observational


Primary Outcome

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


Condition

Tick-Borne Encephalitis, European

Intervention

No intervention


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

50

Start Date

October 1, 2020

Completion Date

December 31, 2023

Primary Completion Date

December 31, 2023

Eligibility Criteria

        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.
      

Gender

All

Ages

16 Years - N/A


Contacts

Hege Kersten, PhD, 47249134, [email protected]

Location Countries

Norway

Location Countries

Norway

Administrative Informations


NCT ID

NCT05138055

Organization ID

96505


Responsible Party

Sponsor

Study Sponsor

Sykehuset Telemark

Collaborators

 Sykehuset i Vestfold HF

Study Sponsor

Hege Kersten, PhD, Study Director, Study director


Verification Date

February 2021