ClinicalTrials.gg
RecruitingNCT07584525Updated May 13, 2026

Dexamethasone in Tick-borne Encephalitis

A Phase 3 interventional study of Dexametasone and Saline (0.9% NaCl) in Tick-Borne Encephalitis, sponsored by University Medical Centre Ljubljana. Recruiting at 1 site in Slovenia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-13.

Sponsored by University Medical Centre Ljubljana · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 11 months after the study started (first participant enrolled May 2024, registered Apr 2026).
  • Started May 2024; still recruiting 2 years 6 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to investigate the efficacy of dexamethasone in patients with tick-borne encephalitis.

02

Conditions studied

  • Tick-Borne Encephalitis
03

In context

Encephalitis, Tick-Borne

51 studies on the registry are indexed under Encephalitis, Tick-Borne; 9 are open to participants now.

This study's planned enrollment of 200 is close to the median of 192 across 32 interventional studies indexed under Encephalitis, Tick-Borne.

Browse Encephalitis, Tick-Borne studies →

Lead sponsor

University Medical Centre Ljubljana is the lead sponsor of 296 studies on the registry; 72 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • pregnancy or
  • severe neurological impairment befor tick-borne encephalitis or
  • systemic treatment in the past 30 days or
  • allergy to corticosteroids or
  • immunosuppresive condition or therapy such as 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
  • endoscopically documented peptic gastric ulcer in the past six months or gastrointestinal bleeding with drop ≥ 20 units or
  • uncontrolled diabetes with hyperglicemia or
  • antiviral therapy with rilpivirin
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
200 participants (estimated)

Study arms

  • Active comparator
    Dexamethasone

    Drug: Dexametasone

  • Placebo comparator
    Placebo

    Drug: Saline (0.9% NaCl)

Interventions

  • dexamethasone 4 mg tid

  • DrugSaline (0.9% NaCl)

    20 ml saline

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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)

    Time frame: at the 2, 6, and 12 month follow-up visits

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — The anonymous data generated or analysed during the trial will be available from the corresponding author upon reasonable request.

Time frame: As expected from September 30 2028

Access criteria: The anonymous data generated or analysed during the trial will be available from the corresponding author upon reasonable request after the study results are published.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started May 2024 (actual). Primary completion is estimated for Sep 2030, 76 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 26, 2026
First posted
May 13, 2026
StartActual
May 3, 2024
Primary completionEst.
Sep 30, 2030
CompletionEst.
Sep 30, 2030
Last update
May 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07584525
Responsible party
Daša Stupica (MD, PhD, assoc. prof., University Medical Centre Ljubljana) — Principal investigator
First posted
May 13, 2026
Start date
May 3, 2024
Primary completion
Sep 30, 2030 (estimated)
Completion
Sep 30, 2030 (estimated)
Last update
May 13, 2026

Study contacts

Daša Stupica, MD, PhD
Contact
dasa.stupica@kclj.si
+386 1 522 94 74

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Discussion

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Studies of the drug tested here: Dexamethasone

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