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NCT Number: NCT07584525

Dexamethasone in Tick-borne Encephalitis

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexametasone

Drug

dexamethasone 4 mg tid

Saline (0.9% NaCl)

Drug

20 ml saline

Primary outcomes

  1. Modified Rankin Scale for Neurologic Disability

    Time frame: 6 month follow-up visit

    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

Secondary outcomes

  1. Incomplete outcome

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

    Proportion 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Daša Stupica, MD, PhD

CONTACT

[email protected]

+386 1 522 94 74

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
May 13, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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