Clinical Trial

Tick-borne Encephalitis and Borrelial Antibodies in Serum

Recruiting
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Summary
In Slovenia, tick-borne encephalitis and Lyme borreliosis are both endemic diseases with high incidence rates and they are both transmitted by a bite of infected Ixodes ricinus tick. In clinical practice, tick-borne encephalitis is confirmed by demonstration of tick-borne encephalitis antibodies in serum of a patient with compatible clinical presentation and cerebrospinal pleocytosis. Patients with Lyme meningitis or meningoradiculitis also have cerebrospinal pleocytosis, however the presence of borrelial antibodies in serum does not attest Lyme neuroborreliosis. Patients with tick-borne encephalitis and positive borrelial antibodies in serum, but not fulfilling criteria for Lyme neuroborreliosis, are often being treated with antibiotics in several European countries due to the possibility of double infection. The investigators hypothesise that such patients do not benefit from antibiotics. Such an approach may appear safe regarding the possibility of borrelial infection, however it can also be associated with detrimental consequences such as antibiotic related adverse reactions, negative epidemiological impact on bacterial resistance, and intravenous catheter related complications.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2019-05-17; most recent amendment 2025-03-24.
Trial Details
NCT Number NCT03956446
Lead Sponsor University Medical Centre Ljubljana
Collaborators: University of Ljubljana School of Medicine, Slovenia
Conditions Tick Borne Encephalitis
Enrollment 80 participants
Start Date 2014-09-01
Primary Completion 2027-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-03-25