Tick-borne Encephalitis and Borrelial Antibodies in Serum

Brief Title

Tick-borne Encephalitis and Borrelial Antibodies in Serum

Official Title

Antibiotic Therapy for Patients With Tick-borne Encephalitis and Borrelial Antibodies in Serum

Brief 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.
    

Study Type

Interventional

Primary Outcome

Number of patients with objective manifestations of Lyme borreliosis

Condition

Tick Borne Encephalitis

Intervention

Doxycycline

Study Arms / Comparison Groups

 Doxycycline, Doxy®

Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

80

Start Date

September 1, 2014

Completion Date

December 31, 2021

Primary Completion Date

December 31, 2021

Eligibility Criteria

        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

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Daša Stupica, MD PhD, +386 31 689324, [email protected]

Location Countries

Slovenia

Location Countries

Slovenia

NCT ID

NCT03956446

Organization ID

TBE-BB prospect

Responsible Party

Principal Investigator

Study Sponsor

University Medical Centre Ljubljana

Collaborators

 University of Ljubljana School of Medicine, Slovenia

Study Sponsor

Daša Stupica, MD PhD, Principal Investigator, University Medical Centre Ljubljana

Verification Date

November 2020