Dexamethasone for tick-borne encephalitis
Treatment With Dexamethasone in Patients With Tick-borne Encephalitis: Randomized Clinical Trial
PHASE3 · University Medical Centre Ljubljana · NCT07584525
This trial will see if dexamethasone helps adults with confirmed tick-borne encephalitis who have meningitis, encephalitis, or meningomyelitis.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Centre Ljubljana (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Ljubljana) |
| Trial ID | NCT07584525 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Prior research on corticosteroid use in tick-borne encephalitis is limited and inconclusive, so the benefit of this approach is not yet established.
Eligibility criteria
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 this trial is running
Ljubljana
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Tick-Borne Encephalitis