Investigating tick-borne encephalitis and borrelial antibodies in patients
Official title: Antibiotic Therapy for Patients With Tick-borne Encephalitis and Borrelial Antibodies in Serum
Run by University Medical Centre Ljubljana · NCT03956446 · Data updated 2026-11-12
This study is testing if giving antibiotics helps patients in Slovenia with tick-borne encephalitis symptoms and positive borrelial antibodies, even if they don't have Lyme disease.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | University Medical Centre Ljubljana Academic / other |
| Locations | 1 site (Ljubljana) |
| Status | Recruiting |
| Started | September 1, 2014 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | March 25, 2025 |
| Trial ID | NCT03956446 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with clinical signs of tick-borne encephalitis and specific laboratory findings.
✕Probably not a fit
Patients who have confirmed Lyme neuroborreliosis or recent borrelial infections will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study examines patients in Slovenia who present with symptoms of tick-borne encephalitis and have positive borrelial antibodies in their serum. The researchers aim to determine whether these patients benefit from antibiotic treatment, given that they may not have Lyme neuroborreliosis despite the presence of borrelial antibodies. The study involves administering doxycycline and symptomatic therapy while collecting data through questionnaires. The goal is to clarify treatment protocols for patients with potential double infections.
Why it matters
Potential benefit: If successful, this study could lead to more accurate treatment protocols for patients with tick-borne encephalitis and reduce unnecessary antibiotic use.
How similar studies have gone: While there is limited data on this specific approach, similar studies have explored the complexities of co-infections and treatment efficacy, indicating a need for further investigation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years or older * clinical picture compatible with tick-borne encephalitis, * clear cerebrospinal fluid, * cerebrospinal pleocytosis (leucocytes in cerebrospinal fluid \>5 x 106/)L, * positive serum immunoglobulin M (IgM) and immunoglobulin G (IgG) antibodies against tick-borne encephalitis virus, * positive serum IgG antibodies against Lyme borreliae. Exclusion Criteria: * isolation of B.burgdorferi sensu lato from cerebrospinal fluid, * positive intrathecal borrelial antibody production index, * seroconversion of borrelial IgG antibodies, * presence of erythema migrans and/or borrelial lymphocytoma in the last month, * Bannwarth syndrome.
Where it's running
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University Medical Center Ljubljana
Ljubljana, Slovenia Recruiting
Study contacts
- Principal investigator: Daša Stupica, MD PhD — University Medical Centre Ljubljana
- Study coordinator: Daša Stupica, MD PhD
- Email: dasa.stupica@kclj.si
- Phone: +386 31 689324
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Dexamethasone for tick-borne encephalitis
This trial will see if dexamethasone helps adults with confirmed tick-borne encephalitis who have meningitis, encephalitis, or meningomyelitis.
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Tick-borne infections in Finland: a broad, multicenter look at Lyme, TBE and other infections
This study tests how common and how these infections show up in people with suspected tick-borne disease in Finland.
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Community spread of multiple infectious diseases in Cambodia from a One Health perspective
This project will test how common and connected dengue, chikungunya, Zika, Japanese encephalitis, and West Nile infections are among people, animals, and the environment across Cambodia.
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Long-term recovery and vaccination cost-effectiveness for tick-borne encephalitis in the Czech Republic
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.
-
General practitioners' knowledge of tick-borne encephalitis in France
This project will test how well general practitioners in France recognize and manage tick-borne encephalitis after a tick bite.
-
Observational study on tick-borne diseases in Sweden
This study is trying to learn more about new tick-borne diseases in Sweden and how to better diagnose and treat people who might have them.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.