Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT03956446

Tick-borne Encephalitis and Borrelial Antibodies in Serum

Led by University Medical Centre Ljubljana · Updated on 2025-03-25

80

Participants Needed

1

Research Sites

695 weeks

Total Duration

On this page

Sponsors

U

University Medical Centre Ljubljana

Lead Sponsor

U

University of Ljubljana School of Medicine, Slovenia

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Tick-borne Encephalitis and Borrelial Antibodies in Serum

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years or older
  • Clinical picture compatible with tick-borne encephalitis
  • Clear cerebrospinal fluid
  • Cerebrospinal pleocytosis (leucocytes in cerebrospinal fluid >5 x 10^6/L)
  • Positive serum IgM and IgG antibodies against tick-borne encephalitis virus
  • Positive serum IgG antibodies against Lyme borreliae
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University Medical Center Ljubljana

Ljubljana, Slovenia

Actively Recruiting

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Research Team

D

Daša Stupica, MD PhD

CONTACT

M

Maša Velušček, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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