Dexamethasone in Tick-borne Encephalitis
ConditionTick-Borne Encephalitis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Medical Centre Ljubljana
About this trial
The purpose of this study is to investigate the efficacy of dexamethasone in patients with tick-borne encephalitis.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
pregnancy or
severe neurological impairment befor tick-borne encephalitis or
systemic corticosteroid treatment in the past 30 days or
allergy to corticosteroids or
Trial design
Design model
Parallel
Treatments tested in this trial
Dexametasone
Drugdexamethasone 4 mg tid
Saline (0.9% NaCl)
Drug20 ml saline
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: DexamethasoneActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
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
Time frame
6 month follow-up visitSecondary outcomes
1
Incomplete outcome
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)
Time frame
at the 2, 6, and 12 month follow-up visitsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov