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Tick Borne Encephalitis (TBE)ENCZECHNCT07274046

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

An observational study of Tick Borne Encephalitis (TBE), run by Charles University, Czech Republic at 4 sites in Czechia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Tick Borne Encephalitis (TBE)
How many people
209 participants
Where
4 sitesCzechia
Study dates
1 Apr 2023to Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study 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.

Who may be able to join

  • Hospitalization due to suspected central nervous system (CNS) infection.
  • Laboratory-confirmed TBE, defined as:
  • the presence of CNS symptoms and cerebrospinal fluid pleocytosis (>5 × 10⁶/L) and TBEV IgM and IgG seropositivity in serum, or detection of TBEV IgM in CSF in previously vaccinated individuals.
  • 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).

Who cannot join

  • 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.
  • Coexisting severe neurological disorder unrelated to TBE that prevents meaningful evaluation of sequelae (e.g., advanced neurodegenerative disease, severe preexisting motor disability).

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Martin Slížek, MD contact

00420602269494

martin.slizek89@gmail.com

Czechia4 sites, 4 recruiting
  • České Budějovice Hospital

    České Budějovice, South Bohemian Region, 37001

    Vojtěch Pražák, MD, 00420387874601, infekcni@nemcb.cz

    Vojtěch Pražák, MD

    Recruiting
  • Ostrava University Hospital

    Ostrava, Moravian-Silesian Region, 70800

    Kateřina Pohludková, MD, 00420 597 373 480, katerina.pohludkova@fno.cz

    Kateřina Pohludková, MD

    Recruiting
  • Pardubická nemocnice

    Pardubice, Pardubice Region, 53001

    Lukáš Chovanec, MD, +420 466 014 613, lukas.chovanec@nempk.cz

    Lukáš Chovanec, MD

    Recruiting
  • Bulovka University Hospital

    Prague, Prague, 18081

    Martin Slížek, MD, 00420602269494, martin.slizek89@gmail.com

    Martin Slížek, MD

    Recruiting

Other trials in Czechia

About this study

Official title: Clinical and Public-Health Impact of Tick-Borne Encephalitis: A Prospective Multicenter Observational Study With 12-Month Follow-up and Cost-Effectiveness Analysis

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.

Read the detailed description

Tick-borne encephalitis (TBE) is a serious viral infection of the central nervous system and represents a longstanding public-health challenge in the Czech Republic, a country with one of the highest TBE incidences in Europe. Although an effective vaccine has been available for decades, population-level vaccination coverage remains low, resulting in persistently high incidence across all age groups and numerous severe cases requiring hospitalization. Despite extensive clinical experience with TBE, the long-term course of the disease, the full spectrum of postencephalitic syndrome (PES), and the associated functional and neurocognitive burden remain incompletely quantified in contemporary, real-world populations. Updated evidence is also needed to inform public-health planning and to evaluate the potential health and economic benefits of broader TBE vaccination in this high-endemicity setting.

The study is a prospective multicenter observational investigation enrolling children and adults hospitalized with laboratory-confirmed TBE across four major infectious disease centers in the Czech Republic. Standardized clinical and functional assessments are applied to capture both the acute clinical course and the long-term recovery trajectory. Acute disease severity is classified using predefined clinical criteria, including the presence of motor deficit (paresis) during hospitalization, intensive-care unit admission, prolonged hospitalization (length of stay >10 days), or death. Follow-up assessments occur at 2-4 weeks, 3 months, 6 months, and 12 months after discharge.

Long-term outcomes are evaluated using validated tools, including the modified Rankin Scale (mRankin) to assess global functional disability and the Minimum European Health Module (MEHM) to capture self-perceived health, activity limitation, and chronic morbidity. A central focus of the study is the characterization of postencephalitic syndrome (PES), the most common long-term complication of TBE. PES is defined as the persistence of one or more neurological, cognitive, or functional symptoms lasting for at least 6 months after acute infection. These symptoms may include chronic fatigue, impaired concentration or memory, cognitive slowing, sleep disturbances, headaches, irritability, anxiety, or reduced exercise tolerance. Persistent motor deficits, such as paresis or impaired coordination, are evaluated as integral components of PES, reflecting a more severe neurological phenotype. Detailed symptom-level data and functional assessments are collected to comprehensively describe the prevalence, severity, and heterogeneity of PES and its impact on long-term quality of life.

The study examines demographic and clinical predictors of adverse outcomes, including the role of age, comorbidities, markers of central nervous system involvement during the acute phase, and initial disease severity. These analyses are intended to support improved prognostic counseling and inform follow-up and rehabilitation strategies.

A public-health and economic component quantifies the overall burden of TBE in disability-adjusted life years (DALYs), integrating observed functional outcomes, sequelae duration, disability weights, and TBE-related mortality. DALY estimates are combined with national epidemiological surveillance data to ensure representativeness across age groups and regions. These outcomes will form the basis for a decision-analytic model evaluating the cost-effectiveness of increasing TBE vaccination coverage. The model compares current vaccination uptake with expanded coverage scenarios across different age groups and generates estimates of incremental cost-effectiveness ratios (ICERs), projected health gains, reductions in long-term disability, and potential healthcare cost savings. The economic modeling relies solely on aggregated clinical and epidemiological data and does not include any patient-level interventions.

By integrating prospective clinical follow-up, standardized functional assessments, detailed characterization of PES, and health-economic modeling, the study provides a comprehensive evaluation of the clinical and economic burden of TBE in the Czech Republic. The findings may inform clinical practice, long-term patient management, and national vaccination policy, contributing to improved prevention and mitigation of TBE-related morbidity.

Being tested
No intervention
Keywords
tick-borne encephalitis, sequelae, post-encephalitic syndrome, age, TBEV, encephalitis, cost-effectiveness
Medical subject headings
Encephalitis, Tick-Borne, Encephalitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionOther

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

Study groups in NCT07274046
Study groupRoleWhat they receive
TBE cohortChildren and adults hospitalized with confirmed tick-borne encephalitis, followed prospectively for 12 months.
Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months post-discharge and 12 months post-discharge

Secondary outcomes (11)
  1. Persistent Motor Deficit

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

    Measured: 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.

    Measured: During index hospitalization

  3. Functional Status by Modified Rankin Scale (mRankin)

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

    Measured: 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.

    Measured: 2-4 weeks post-discharge; 3 months; 6 months; 12 months

  5. Persistence or Resolution of Individual PES Symptoms (Structured Symptom Checklist)

    This outcome is assessed using a structured PES Symptom Checklist developed for standardized evaluation of post-encephalitic symptoms. The checklist captures the presence or absence of individual symptoms associated with post-encephalitic syndrome (PES), including fatigue, exertion intolerance, headache, cognitive slowing, memory problems, concentration difficulties, sleep disturbances, sensory deficits, and emotional instability.

    Each symptom is recorded as present or absent at each follow-up assessment.

    The outcome will be reported as:

    number of symptoms present (range 0-X), and presence/absence of each individual symptom (binary assessment).

    Unit of Measure:

    Number of symptoms (count) and binary presence/absence for each symptom

    Measured: 2-4 weeks post-discharge; 3 months; 6 months; 12 months

  6. Hospital Length of Stay (LOS)

    Total duration of the index hospital stay in days, from hospital admission for acute TBE to hospital discharge.

    Measured: From hospital admission to hospital discharge, assessed over an expected hospitalization period of up to 90 days.

  7. ICU Admission

    Whether the patient was admitted to intensive care during acute TBE and the length of ICU stay.

    Measured: From hospital admission to hospital discharge, including any ICU stay, assessed over an expected hospitalization period of up to 90 days.

  8. All-Cause Mortality (binary outcome)

    All-cause mortality recorded as a binary outcome (alive/deceased) at predefined time points. Mortality during the index hospitalization and mortality during follow-up (6 and 12 months post-discharge) are recorded separately.

    Unit of Measure: Proportion of participants deceased (%)

    Measured: During index hospitalization; 6 months post-discharge; 12 months post-discharge

  9. Cost-Effectiveness of TBE Vaccination

    Cost-effectiveness of increasing TBE vaccination coverage in the Czech Republic based on disability-adjusted life years (DALYs) derived from observed functional outcomes (mRankin, MEHM), PES prevalence, symptom duration, and TBE-associated mortality. A decision-analytic model will estimate incremental cost-effectiveness ratios (ICERs) across different age groups and vaccination coverage scenarios using real-world clinical data combined with national surveillance data.

    Measured: Final analysis at 12 months after completion of follow-up.

  10. Change in Functional Status (modified Rankin Scale, mRankin)

    Change in global functional disability assessed using the modified Rankin Scale (0-6). Scores are recorded at each follow-up visit to evaluate recovery trajectory and functional outcomes after acute TBE.

    Measured: Baseline (hospitalization), 2-4 weeks post-discharge, 3 months, 6 months, 12 months.

  11. Change in Self-Perceived Health (Minimum European Health Module, MEHM)

    Change in self-perceived health, activity limitation, and chronic morbidity assessed using the Minimum European Health Module (MEHM).

    Unit of Measure: MEHM score (categorical responses)

    Measured: Baseline (hospitalization), 2-4 weeks post-discharge, 3 months, 6 months, 12 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2025
  2. Study start1 Apr 2023
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
209 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07274046
Sponsor's protocol ID
TBE-CZ-OBS-2023-01
Other IDs
06_SM_FNB_002
Acronym
ENCZECH
Status last verified
Dec 2025
First submitted
19 Nov 2025
Last updated
10 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared. Only aggregated, anonymized results will be made available in publications.

Questions about this trial

What is this clinical trial studying?

An observational study of Tick Borne Encephalitis (TBE), run by Charles University, Czech Republic at 4 sites in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Martin Slížek, MD (00420602269494, martin.slizek89@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Presence and Severity of Post-Encephalitic Syndrome (PES) (time frame: 6 months post-discharge and 12 months post-discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.

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