Long-term recovery and vaccination cost-effectiveness for tick-borne encephalitis in the Czech Republic
Clinical and Public-Health Impact of Tick-Borne Encephalitis: A Prospective Multicenter Observational Study With 12-Month Follow-up and Cost-Effectiveness Analysis
This project follows children and adults hospitalized with tick-borne encephalitis in the Czech Republic to see how they recover, which symptoms persist, and to estimate the health and economic benefits of vaccination.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 209 (estimated) |
| Sex | All |
| Sponsor | Charles University, Czech Republic Academic / other |
| Locations | 4 sites (Ostrava, Moravian-Silesian Region and 3 other locations) |
| Trial ID | NCT07274046 on ClinicalTrials.gov |
What this trial studies
This is a prospective multicenter observational study enrolling children and adults hospitalized with laboratory-confirmed TBE across major Czech infectious disease centers. Participants receive standardized clinical, functional, and quality-of-life assessments at discharge and at 2–4 weeks, 3 months, 6 months, and 12 months to map recovery trajectories and identify persistent symptoms characterized as post-encephalitic syndrome. Acute disease severity is categorized using predefined clinical criteria including paresis, ICU admission, prolonged hospitalization, or death. The dataset is combined with health-economic analyses to model the potential population-level impact and cost-effectiveness of broader TBE vaccination in this high-incidence setting.
Who should consider this trial
Good fit: Ideal participants are children or adults hospitalized with laboratory-confirmed TBE who can provide informed consent (or have a legal guardian provide consent) and can attend or be contacted for scheduled follow-up assessments.
Not a fit: Patients without laboratory confirmation of TBE, those with an alternative diagnosis explaining their neurological symptoms, or those unable to complete follow-up are unlikely to gain direct benefit from the study's clinical or policy findings.
Why it matters
Potential benefit: If successful, the findings could improve post-TBE follow-up and rehabilitation and inform vaccination policies that reduce future cases and long-term disability.
How similar studies have performed: Previous cohort studies have documented persistent post-encephalitic symptoms and economic models have supported TBE vaccination in some settings, but large prospective multicenter data linking clinical sequelae and cost-effectiveness in a high-incidence country remain relatively limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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). Exclusion Criteria: * 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).
Where this trial is running
Ostrava, Moravian-Silesian Region and 3 other locations
- Ostrava University Hospital — Ostrava, Moravian-Silesian Region, Czechia (Recruiting)
- Pardubická nemocnice — Pardubice, Pardubice Region, Czechia (Recruiting)
- Bulovka University Hospital — Prague, Prague, Czechia (Recruiting)
- České Budějovice Hospital — České Budějovice, South Bohemian Region, Czechia (Recruiting)
Study contacts
- Study coordinator: Martin Slížek, MD
- Email: martin.slizek89@gmail.com
- Phone: 00420602269494
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.