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

Status: Recruiting
Intervention Type: Other
Study Type: Observational
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. 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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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).

Contact Information
Primary
Martin Slížek, MD
martin.slizek89@gmail.com
00420602269494
Time Frame
Start Date: 2023-04-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 209
Treatments
TBE cohort
Children and adults hospitalized with confirmed tick-borne encephalitis, followed prospectively for 12 months.
Related Therapeutic Areas
Sponsors
Collaborators: Bulovka Hospital, University Hospital Ostrava, České Budějovice Hospital, Hospital Pardubice
Leads: Charles University, Czech Republic

This content was sourced from clinicaltrials.gov

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