Tick-borne Encephalitis and Borrelial Antibodies in Serum
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Doxycycline, Symptomatic therapy, Questionnaire.
- Who it may be relevant to
- Registry conditions: Tick Borne Encephalitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Slovenia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Antibiotic Therapy for Patients With 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.
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.
Primary outcome measures
- Number of patients with objective manifestations of Lyme borreliosis [Time frame: one year]
- Frequency of nonspecific symptoms such as headache, fatigue, arthralgia, myalgia [Time frame: one year]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Slovenia · 1 center
- University Medical Center Ljubljana — Ljubljana
Identifiers
NCT: NCT03956446 · TBE-BB prospect