Infectious EncephalitisNCT06593249
Management of Tick-borne Encephalitis
An observational study of Infectious Encephalitis, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
In this retrospective cohort study of patients with tick-borne encephalitis (TBE), potential differences in the clinical presentation at admission and diagnostic and therapeutic management of patients with TBE initially referred to infectious diseases or neurology departments were assessed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infectious Encephalitis
- How many people
- 318 participants
- Where
- 1 siteSlovenia
- Study dates
- 30 Sep 2022to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with tick-borne encepalitis referred to Infectious diseases or Neurology departments of the University Medical Centre Ljubljana, Slovenia during the COVID-19 pandemic (from March 2020 to September 2022).
Who may be able to join
- microbiologically confirmed tick-borne meningoencephalitis
Who cannot join
- Exchanged between ID and neurology within the first 48 hours due to organizational constraints
- Transferred from another hospital
- Lumbar puncture not performed
- Not fulfilling study criteria
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
University Medical Centre Ljubljana, Ljublajana, Slovenia
Ljubljana
About this study
Official title: Presentation, Management and Outcome of Tick-borne Encephalitis in Patients Referred to Infectious Diseases or Neurology
In this retrospective cohort study of patients with tick-borne encephalitis (TBE), potential differences in the clinical presentation at admission and diagnostic and therapeutic management of patients with TBE initially referred to infectious diseases or neurology departments were assessed. Associations between severity of acute illness and clinical outcome were also explored.
- Conditions
- Infectious Encephalitis
- Being tested
- No Intervention: Observational Cohort
- Keywords
- tick-borne encephalitis, outcome, neuroimaging, lumbar puncture, clinical management
- Medical subject headings
- Infectious Encephalitis, Encephalitis, Tick-Borne
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
no intervention, observational study
| Study group | Role | What they receive |
|---|---|---|
| TBE in Infectious Diseases Department | patients with TBE referred to ID Receives: Other: No Intervention: Observational Cohort | |
| TBE in Neurology Department | Patients with TBE in Neurology Department Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
head imaging
Number (%) of patients with head imaging performed before proceeding to lumbar puncture.
Measured: at admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start30 Sep 2022
- Primary completion30 Sep 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious EncephalitisStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06593249
- Sponsor's protocol ID
- TBE in ID or Neurology
- Status last verified
- Mar 2020
- First submitted
- 9 Sep 2024
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: On reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Presentation, Management and Outcome of Tick-borne Encephalitis in Patients Referred to Infectious Diseases or Neurology
- ClinicalTrials.gov ID
- NCT06593249
- Acronym / sponsor ID
- TBE in ID or Neurology
- Conditions
- Infectious Encephalitis
- Keywords
- tick-borne encephalitis, outcome, neuroimaging, lumbar puncture, clinical management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 19 Sep 2024 (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.
In this retrospective cohort study of patients with tick-borne encephalitis (TBE), potential differences in the clinical presentation at admission and diagnostic and therapeutic management of patients with TBE initially referred to infectious diseases or neurology departments were assessed. Associations between severity of acute illness and clinical outcome were also explored.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TBE in Infectious Diseases Department | – | Other: No Intervention: Observational Cohortpatients with TBE referred to ID |
| TBE in Neurology Department | – | Other: No Intervention: Observational CohortPatients with TBE in Neurology Department |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with tick-borne encepalitis referred to Infectious diseases or Neurology departments of the University Medical Centre Ljubljana, Slovenia during the COVID-19 pandemic (from March 2020 to September 2022).
Key inclusion criteria (1 listed)
- microbiologically confirmed tick-borne meningoencephalitis
Key exclusion criteria (4 listed)
- Exchanged between ID and neurology within the first 48 hours due to organizational constraints
- Transferred from another hospital
- Lumbar puncture not performed
- Not fulfilling study criteria
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 Intervention: Observational Cohortno intervention, observational study | Other | TBE in Infectious Diseases Department, TBE in Neurology Department |
Primary outcome
head imaging
Time frame: at admission
Number (%) of patients with head imaging performed before proceeding to lumbar puncture.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Individual participant dataSharing planned: Undecided. On reasonable request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infectious Encephalitis, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
head imaging (time frame: at admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Dec 2024.