Clinical trial Recruiting at 1 site Interventional Ages 18 and up

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.

More Tick-Borne Diseases trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment80 (estimated)
SponsorUniversity Medical Centre Ljubljana
Academic / other
Locations1 site (Ljubljana)
StatusRecruiting
StartedSeptember 1, 2014
Main results expectedDecember 31, 2027
Study endsDecember 31, 2027
Registry record updatedMarch 25, 2025
Trial IDNCT03956446 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

  • 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

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.