Tick-Borne EncephalitisPhase 3NCT07584525
Dexamethasone in Tick-borne Encephalitis
A Phase 3 study testing Dexametasone and Saline (0.9% NaCl) in people with Tick-Borne Encephalitis, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
The purpose of this study is to investigate the efficacy of dexamethasone in patients with tick-borne encephalitis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tick-Borne Encephalitis
- What is being tested?
- Dexametasone and Saline (0.9% NaCl)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteSlovenia
- Study dates
- 3 May 2024to 30 Sep 2030
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18 years or older and
- clinical signs and symptoms of meningoencephalitis or meningomyelitis and
- cerebrospinal pleocytosis and
- serological confirfmation of tick-borne encephalitis virus infection
Who cannot join
- pregnancy or
- severe neurological impairment befor tick-borne encephalitis or
- systemic corticosteroid treatment in the past 30 days or
- allergy to corticosteroids or
- immunosuppresive condition or therapy such as HIV with CD4 < 200/ml, organ or bone marrow transplant, receiving chemotherapy, radiotherapy or any other immunosuppresive therapy, primary immunodeficiency, hematological maliganncy or
- ventricular shunt or
Show all 9Show fewer
- endoscopically documented peptic gastric ulcer in the past six months or gastrointestinal bleeding with hemoglobin drop ≥ 20 units or
- uncontrolled diabetes with hyperglicemia or
- antiviral therapy with rilpivirin
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia1 site, 1 recruiting
- Recruiting
University Medical Centre Ljubljana
Ljubljana, 1000
Daša Stupica, +386 1 522 94 74, dasa.stupica@kclj.si
About this study
Official title: Treatment With Dexamethasone in Patients With Tick-borne Encephalitis: Randomized Clinical Trial
The purpose of this study is to investigate the efficacy of dexamethasone in patients with tick-borne encephalitis.
- Conditions
- Tick-Borne Encephalitis
- Being tested
- Dexametasone, Saline (0.9% NaCl)
- 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.
DexametasoneDrug
dexamethasone 4 mg tid
Saline (0.9% NaCl)Drug
20 ml saline
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Active comparator | Not described Receives: Drug: Dexametasone |
| Placebo | Placebo comparator | Not described Receives: Drug: Saline (0.9% NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale for Neurologic Disability
Proportion of patients with score 2 or higher on Modified Rankin Scale for Neurologic Disability, avilable at: https://www.mdcalc.com/calc/1890/modified-rankin-scale-neurologic-disability
Measured: 6 month follow-up visit
Secondary outcomes (1)
Incomplete outcome
Proportion of patients with objective sequelae and subjective symptoms post tick-borne encephalitis as detected by performing clinical examination (objective sequelae) and taking patient history (subjective symptoms)
Measured: at the 2, 6, and 12 month follow-up visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start3 May 2024
- Primary completion30 Sep 2030 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tick-Borne 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daša Stupica, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07584525
- Sponsor's protocol ID
- TBE-Dexa
- Status last verified
- Apr 2026
- First submitted
- 26 Apr 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The anonymous data generated or analysed during the trial will be available from the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment With Dexamethasone in Patients With Tick-borne Encephalitis: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07584525
- Acronym / sponsor ID
- TBE-Dexa
- Conditions
- Tick-Borne Encephalitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 3 May 2024 (actual)
- Primary completion
- 30 Sep 2030 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 13 May 2026 (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.
The purpose of this study is to investigate the efficacy of dexamethasone in patients with tick-borne encephalitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Active comparator | Drug: Dexametasone |
| Placebo | Placebo comparator | Drug: Saline (0.9% NaCl) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18 years or older and
- clinical signs and symptoms of meningoencephalitis or meningomyelitis and
- cerebrospinal pleocytosis and
- serological confirfmation of tick-borne encephalitis virus infection
Key exclusion criteria (9 listed)
- pregnancy or
- severe neurological impairment befor tick-borne encephalitis or
- systemic corticosteroid treatment in the past 30 days or
- allergy to corticosteroids or
- immunosuppresive condition or therapy such as HIV with CD4 < 200/ml, organ or bone marrow transplant, receiving chemotherapy, radiotherapy or any other immunosuppresive therapy, primary immunodeficiency, hematological maliganncy or
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 |
|---|---|---|
| Dexametasonedexamethasone 4 mg tid | Drug | Dexamethasone |
| Saline (0.9% NaCl)20 ml saline | Drug | Placebo |
Primary outcome
Modified Rankin Scale for Neurologic Disability
Time frame: 6 month follow-up visit
Proportion of patients with score 2 or higher on Modified Rankin Scale for Neurologic Disability, avilable at: https://www.mdcalc.com/calc/1890/modified-rankin-scale-neurologic-disability
1 secondary outcome
Incomplete outcome
Time frame: at the 2, 6, and 12 month follow-up visits
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 13 May 2026.
- Individual participant dataSharing planned: Yes. The anonymous data generated or analysed during the trial will be available from the corresponding author upon 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexametasone and Saline (0.9% NaCl) in people with Tick-Borne 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 4 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 13 May 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Daša Stupica, MD, PhD (+386 1 522 94 74, dasa.stupica@kclj.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale for Neurologic Disability (time frame: 6 month follow-up visit). 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 May 2026.