Tick-borne Encephalitis and Borrelial Antibodies in Serum

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.

Full Title of Study: “Antibiotic Therapy for Patients With Tick-borne Encephalitis and Borrelial Antibodies in Serum”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2020

Interventions

  • Drug: Doxycycline
    • Beside symptomatic therapy, patients will receive oral Doxycycline 100 mg, Doxy® twice daily.
  • Drug: Symptomatic therapy
    • 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.
  • Other: Questionnaire
    • Subjects will be asked to answer a questionnaire asking about the presence and frequency of nonspecific symptoms such as headache, fatigue, arthralgia, myalgia.

Arms, Groups and Cohorts

  • Active Comparator: Doxycycline, Doxy®
    • Beside symptomatic therapy, patients will receive oral doxycycline 100 mg (Doxy®) twice daily. Patients will answer a questionnaire asking about the presence and frequency of nonspecific symptoms such as headache, fatigue, arthralgia, myalgia.
  • Other: No antibiotics
    • Patients will receive symptomatic therapy (paracetamol, Lekadol®, granisetron, Kytril®, metamizol, Analgin®, parenteral hydration with saline). Patients will answer a questionnaire asking about the presence and frequency of nonspecific symptoms such as headache, fatigue, arthralgia, myalgia.
  • Other: Healthy controls
    • Patients will be asked to refer a spouse to serve as a control. If unmarried they will be asked to refer a family member or a friend of +/- 5 years to serve as a control. Control subjects will be asked to answer a questionnaire asking about the presence and frequency of nonspecific symptoms such as headache, fatigue, arthralgia, myalgia.

Clinical Trial Outcome Measures

Primary Measures

  • Number of patients with objective manifestations of Lyme borreliosis
    • Time Frame: one year
    • 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.
  • Frequency of nonspecific symptoms such as headache, fatigue, arthralgia, myalgia
    • Time Frame: one year

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University Medical Centre Ljubljana
  • Collaborator
    • University of Ljubljana School of Medicine, Slovenia
  • Provider of Information About this Clinical Study
    • Principal Investigator: Daša Stupica, Prinicipal Investigator – University Medical Centre Ljubljana
  • Overall Official(s)
    • Daša Stupica, MD PhD, Principal Investigator, University Medical Centre Ljubljana
  • Overall Contact(s)
    • Daša Stupica, MD PhD, +386 31 689324, dasa.stupica@kclj.si

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