Tick-Borne Encephalitis, EuropeanNOTESNCT05138055
The NOrwegian Tick-borne Encephalitis Study
An observational study of Tick-Borne Encephalitis, European, run by Sykehuset Telemark at 3 sites in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Tick-Borne Encephalitis, European
- How many people
- 153 participants
- Where
- 3 sitesNorway
- Study dates
- 1 Oct 2020to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Norway3 sites
Sykehuset Sørlandet HF
Arendal
Sykehuset Telemark HF
Skien, Telemark, 3710
Sykehuset i Vestfold
Tønsberg
About this study
Official title: The NOrwegian Tick-borne Encephalitis Study - NOTES: An Observational Study on Clinical Features, Long-term Outcomes and Immune Characteristics
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.
Read the 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.
- Conditions
- Tick-Borne Encephalitis, European
- Being tested
- No intervention
- Medical subject headings
- Encephalitis, Tick-Borne
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start1 Oct 2020
- Primary completion31 Dec 2023
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tick-Borne Encephalitis, EuropeanStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sykehuset Telemark
- Sponsor type
- Other government
- Collaborators
- Sykehuset i Vestfold HF, Norwegian Institute of Public Health, Sorlandet Hospital HF, Oslo University Hospital
- Responsible party
- Sponsor
- Investigators
- Hege Kersten, PhD, Study director, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05138055
- Sponsor's protocol ID
- 96505
- Acronym
- NOTES
- Status last verified
- Sep 2024
- First submitted
- 3 Feb 2021
- Last updated
- 25 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26810689
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The NOrwegian Tick-borne Encephalitis Study - NOTES: An Observational Study on Clinical Features, Long-term Outcomes and Immune Characteristics
- ClinicalTrials.gov ID
- NCT05138055
- Acronym / sponsor ID
- NOTES / 96505
- Conditions
- Tick-Borne Encephalitis, European
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Sykehuset TelemarkOther government
- Collaborators
- Sykehuset i Vestfold HF, Norwegian Institute of Public Health, Sorlandet Hospital HF, Oslo University Hospital
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 30 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
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
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.
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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Background: PubMed 26810689Veje 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hege Kersten, PhD study director
Study director
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tick-Borne Encephalitis, European, run by Sykehuset Telemark at 3 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To describe the acute phase clinical and immunological characteristics of TBE in Norway (time frame: 4 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05138055, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.