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 Information
Recruitment Status
Drug
Estimated Enrollment
80
Start Date
September 1, 2014
Completion Date
December 31, 2023
Primary Completion Date
December 31, 2023
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
Administrative Informations
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
May 2022