Tick-borne Encephalitis and Borrelial Antibodies in Serum

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Medical Centre Ljubljana

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

18 years or older

clinical picture compatible with tick-borne encephalitis,

clear cerebrospinal fluid,

cerebrospinal pleocytosis (leucocytes in cerebrospinal fluid >5 x 106/)L,

Disqualifiers

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,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Doxycycline

    Drug

    Beside symptomatic therapy, patients will receive oral Doxycycline 100 mg, Doxy® twice daily.

  • Symptomatic therapy

    Drug

    Patients will receive symptomatic therapy with antipyretics, analgetics, antiemetics, and parenteral hydration: metamizole, Analgin®, paracetamol, Lekadol®, thiethylperazine, Kytril®, saline. Questionnaire Subjects will be asked to answer a questionnaire asking about the presence and frequency of nonspecific symptoms such as headache, fatigue, arthralgia, myalgia.

  • Questionnaire

    Other intervention

    Subjects will be asked to answer a questionnaire asking about the presence and frequency of nonspecific symptoms such as headache, fatigue, arthralgia, myalgia.

Treatment groups

80 Participants
are divided into 3 treatment groups
Group A: Doxycycline, Doxy®Active comparator 3 interventions
Group B: No antibioticsOther 2 interventions
Group C: Healthy controlsOther 1 intervention

Trial outcomes

Primary outcomes

1

Number of patients with objective manifestations of Lyme borreliosis

At each visit physical examination will be performed and clinical signs indicating objective manifestations of Lyme borreliosis, such as erythema migrans, will be searched for.

Time frame
one year
2

Frequency of nonspecific symptoms such as headache, fatigue, arthralgia, myalgia

Time frame
one year

Secondary outcomes

Other outcomes

Sponsors and contacts

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University Medical Centre Ljubljana

Lead sponsor

University of Ljubljana School of Medicine, Slovenia

Collaborator