RecruitingNot ApplicableNCT03956446

Tick-borne Encephalitis and Borrelial Antibodies in Serum

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


Sponsor

University Medical Centre Ljubljana

Enrollment

80 participants

Start Date

Sep 1, 2014

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at antibodies in the blood of people who have been diagnosed with tick-borne encephalitis (a viral brain infection spread by tick bites) to better understand how the immune system responds and whether there is overlap with Lyme disease (a bacterial tick-borne illness) in the same patients. **You may be eligible if...** - You are 18 years or older - You have symptoms consistent with tick-borne encephalitis - Your spinal fluid is clear and shows elevated white blood cells (indicating inflammation) - Your blood tests show positive IgM and IgG antibodies against the tick-borne encephalitis virus **You may NOT be eligible if...** - Your spinal fluid is cloudy or shows signs of bacterial infection - Your antibody tests for tick-borne encephalitis are negative - You cannot or will not provide blood or spinal fluid samples Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDoxycycline

Beside symptomatic therapy, patients will receive oral Doxycycline 100 mg, Doxy® twice daily.

DRUGSymptomatic 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.

OTHERQuestionnaire

Subjects will be asked to answer a questionnaire asking about the presence and frequency of nonspecific symptoms such as headache, fatigue, arthralgia, myalgia.


Locations(1)

University Medical Center Ljubljana

Ljubljana, Slovenia

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NCT03956446