Tick-borne Encephalitis and Borrelial Antibodies in Serum

University Medical Centre Ljubljana80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Tick Borne Encephalitis

Interventions

DoxycyclineDRUG

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

Symptomatic therapyDRUG

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.

QuestionnaireOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

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