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Clinical Trial 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.


Clinical Trial Description

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Study Design


Related Conditions & MeSH terms


NCT number NCT03956446
Study type Interventional
Source University Medical Centre Ljubljana
Contact Daša Stupica, MD PhD
Phone +386 31 689324
Email dasa.stupica@kclj.si
Status Recruiting
Phase N/A
Start date September 1, 2014
Completion date December 31, 2024

See also
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Active, not recruiting NCT00890422 - Evaluation of Immunogenicity of Different Tick Borne Encephalitis (TBE) Fast Protective Traveler Schemes With Inactivated TBE Whole Virus Vaccine Phase 2
Completed NCT01991067 - Humoral and Cellular Immunity for TBE Vaccination in Allogeneic HSCT Recipients Phase 2
Completed NCT03958058 - Tick-borne Encephalitis and Possible Borrelial Serology
Active, not recruiting NCT04017052 - Application of a TBE-Vaccine in Obese Persons Phase 4