Recruiting NCT07584525
Dexamethasone in Tick-borne Encephalitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dexametasone, Saline (0.9% NaCl).
- Who it may be relevant to
- Registry conditions: Tick-Borne Encephalitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Slovenia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Treatment With Dexamethasone in Patients With Tick-borne Encephalitis: Randomized Clinical Trial
Overview
The purpose of this study is to investigate the efficacy of dexamethasone in patients with tick-borne encephalitis.
Interventions
- Drug Dexametasone
dexamethasone 4 mg tid - Drug Saline (0.9% NaCl)
20 ml saline
Primary outcome measures
- Modified Rankin Scale for Neurologic Disability [Time frame: 6 month follow-up visit]
Secondary outcome measures (1)
- Incomplete outcome [Time frame: at the 2, 6, and 12 month follow-up visits]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Slovenia · 1 center
- University Medical Centre Ljubljana — Ljubljana
Identifiers
NCT: NCT07584525 · TBE-Dexa