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Dexamethasone in Tick-borne Encephalitis

Treatment With Dexamethasone in Patients With Tick-borne Encephalitis: Randomized Clinical Trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07584525
Enrollment
200
Registered
2026-05-13
Start date
2024-05-03
Completion date
2030-09-30
Last updated
2026-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tick-Borne Encephalitis

Brief summary

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

Interventions

dexamethasone 4 mg tid

DRUGSaline (0.9% NaCl)

20 ml saline

Sponsors

University Medical Centre Ljubljana
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Modified Rankin Scale for Neurologic Disability6 month follow-up visitProportion 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

Secondary

MeasureTime frameDescription
Incomplete outcomeat the 2, 6, and 12 month follow-up visitsProportion 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)

Countries

Slovenia

Contacts

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 14, 2026