Dexamethasone in Tick-borne Encephalitis

NCT07584525 | Recruiting Phase 3

• 1 other identifier: TBE-Dexa
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tick-Borne Encephalitis

Outcome Measures

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

  6 month follow-up visit

Secondary Outcomes (1)

• Incomplete outcome

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

Study Arms (2)

Dexamethasone

ACTIVE COMPARATOR

Drug: Dexametasone

Placebo

PLACEBO COMPARATOR

Drug: Saline (0.9% NaCl)

Interventions

Dexametasone DRUG

dexamethasone 4 mg tid

Dexamethasone

Saline (0.9% NaCl) DRUG

20 ml saline

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

RECRUITING

MeSH Terms

Conditions

Encephalitis, Tick-Borne

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Encephalitis, Arbovirus; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infections; Infectious Encephalitis; Arbovirus Infections; Vector Borne Diseases; Tick-Borne Diseases; Virus Diseases; RNA Virus Infections; Flavivirus Infections; Flaviviridae Infections; Encephalitis; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Daša Stupica, MD, PhD

CONTACT

+386 1 522 94 74; dasa.stupica@kclj.si

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, assoc. prof.

Study Record Dates

• First Submitted: April 26, 2026
• First Posted: May 13, 2026
• Study Start: May 3, 2024
• Primary Completion (Estimated): September 30, 2030
• Study Completion (Estimated): September 30, 2030
• Last Updated: May 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

SL (1)