Dexamethasone for tick-borne encephalitis
Official title: Treatment With Dexamethasone in Patients With Tick-borne Encephalitis: Randomized Clinical Trial
Run by University Medical Centre Ljubljana · NCT07584525 · Data updated 2026-11-12
This trial will see if dexamethasone helps adults with confirmed tick-borne encephalitis who have meningitis, encephalitis, or meningomyelitis.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | University Medical Centre Ljubljana Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Ljubljana) |
| Status | Recruiting |
| Started | May 3, 2024 |
| Main results expected | September 30, 2030 |
| Study ends | September 30, 2030 |
| Registry record updated | May 13, 2026 |
| Trial ID | NCT07584525 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 years or older with clinical meningoencephalitis or meningomyelitis, cerebrospinal pleocytosis, and serological confirmation of tick-borne encephalitis are the intended participants.
✕Probably not a fit
Patients who are pregnant, recently treated with systemic corticosteroids, severely neurologically impaired before infection, immunosuppressed, have a recent peptic ulcer or major GI bleed, uncontrolled diabetes, a ventricular shunt, or are receiving excluded antivirals are unlikely to qualify or benefit from enrollment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 3 interventional study conducted at the University Medical Centre Ljubljana comparing dexamethasone to saline in patients with confirmed tick-borne encephalitis. Eligible participants are adults with clinical signs of meningoencephalitis or meningomyelitis, cerebrospinal fluid pleocytosis, and serologic confirmation of tick-borne encephalitis virus infection. Key exclusions include pregnancy, recent systemic corticosteroid use, significant pre-existing neurological impairment, immunosuppression, recent peptic ulcer disease or major GI bleeding, uncontrolled diabetes, ventricular shunt, and certain antivirals. Participants receive either dexamethasone or saline alongside standard care and are followed for clinical and laboratory indicators of recovery and complications.
Why it matters
Potential benefit: If successful, dexamethasone could reduce central nervous system inflammation and improve neurological recovery in affected patients.
How similar studies have gone: Prior research on corticosteroid use in tick-borne encephalitis is limited and inconclusive, so the benefit of this approach is not yet established.
Who can join: the full rules
Show full inclusion / exclusion criteria
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: * 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 * 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
Where it's running
-
University Medical Centre Ljubljana
Ljubljana, Slovenia Recruiting
Study contacts
- Study coordinator: Daša Stupica, MD, PhD
- Email: dasa.stupica@kclj.si
- Phone: +386 1 522 94 74
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.