Burden of Tick-borne Encephalitis and Cost-effectiveness of Vaccination in the Czech Republic

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorCharles University, Czech Republic

About this trial

This observational study follows children and adults who were hospitalized with tick-borne encephalitis (TBE) in the Czech Republic. The aim is to better understand how individuals recover from TBE, which symptoms may persist after the infection, and which patients may require additional support during their recovery. Participants are examined several times after hospital discharge (at 2-4 weeks, 3 months, 6 months, and 12 months) to observe changes in symptoms, functional status, and daily activities. Follow-up assessments include evaluation of common post-infection problems such as tiredness, headaches, memory or concentration difficulties, sleep issues, or limb weakness. Symptoms lasting for several months are categorized as post-encephalitic syndrome (PES).

The study also assesses how TBE affects daily functioning, school and work performance, and overall quality of life using questionnaires and short functional assessments. In addition, the study includes a public-health component that estimates the broader impact of TBE in the population and evaluates the potential benefits of vaccination in preventing long-term health complications.

The findings aim to support improved patient care, follow-up planning, and evidence-based public-health decision-making in the Czech Republic.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Hospitalization due to suspected central nervous system (CNS) infection.

All age groups (children and adults).

Ability to participate in scheduled follow-up (in person or via telephone).

Informed consent provided by the patient or legal guardian (for minors).

Disqualifiers

Alternative diagnosis explaining the CNS symptoms

Missing essential clinical or laboratory data required to confirm TBE or assess outcomes.

Refusal or inability to provide informed consent.

Inability to complete follow-up assessments, including situations where reliable contact cannot be maintained.

Trial population

Hospitalized children and adults with confirmed tick-borne encephalitis (TBE) treated at four infectious disease centers in the Czech Republic. All participants had clinical symptoms of central nervous system involvement, cerebrospinal fluid pleocytosis, and laboratory confirmation of TBEV infection. Patients were enrolled during their acute hospitalization and followed prospectively for up to 12 months as part of a standardized clinical and functional outcome assessment program.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No intervention

    Other intervention

    Observational study only. Participants receive standard clinical care; no experimental or study-specific interventions are administered.

Treatment groups

209 Participants
are divided into 1 treatment group
Group A: TBE cohort1 intervention

Trial outcomes

Primary outcomes

1

Presence and Severity of Post-Encephalitic Syndrome (PES)

PES is defined as the presence of ≥1 neurological, cognitive, or functional symptom persisting ≥6 months after acute TBE. PES severity is graded as: Mild: mRankin = 1, no limitation of usual activities Moderate: mRankin = 2 and/or limited but preserved independence, or poor self-perceived health (MEHM) Severe: mRankin ≥3, severe limitation of daily activities, very poor self-perceived health, or death.

Time frame
6 months post-discharge and 12 months post-discharge

Secondary outcomes

1

Persistent Motor Deficit

Presence of persistent paresis or other objective motor impairment at follow-up attributed to TBE.

Time frame
6 months post-discharge and 12 months post-discharge
2

Acute Disease Severity Classification

Acute course categorized as severe if any of the following criteria are present: motor deficit (paresis) during hospitalization, ICU admission, hospitalization \>10 days, death. All others classified as mild.

Time frame
During index hospitalization
3

Functional Status by Modified Rankin Scale (mRankin)

Global functional disability assessed by mRankin (0-6).

Time frame
2-4 weeks post-discharge; 3 months; 6 months; 12 months
4

Self-perceived Health and Activity Limitation (MEHM Score)

Minimum European Health Module (MEHM), including perceived health, activity limitation, and chronic morbidity.

Time frame
2-4 weeks post-discharge; 3 months; 6 months; 12 months

Other outcomes

Sponsors and contacts

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Charles University, Czech Republic

Lead sponsor

České Budějovice Hospital

Collaborator

University Hospital Ostrava

Collaborator

Hospital Pardubice

Collaborator

Bulovka Hospital

Collaborator