Tick-borne Encephalitis and Positive Borrelial Antibodies

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Brief Title

Tick-borne Encephalitis and Positive Borrelial Antibodies

Official Title

Management of Patients With Tick-borne Encephalitis and Positive Anti-Lyme Borreliae Antibody Results

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

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 Information


Recruitment Status

Drug

Estimated Enrollment

100

Start Date

September 2014

Completion Date

September 2020

Primary Completion Date

September 2020

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

, +386 1 5222110, [email protected]

Location Countries

Slovenia

Location Countries

Slovenia

Administrative Informations


NCT ID

NCT02463942

Organization ID

TBE-LB2014


Responsible Party

Principal Investigator

Study Sponsor

University Medical Centre Ljubljana

Collaborators

 University of Ljubljana School of Medicine, Slovenia

Study Sponsor

, , 


Verification Date

May 2018