NCT02463942

Tick-borne Encephalitis and Positive Borrelial Antibodies

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University Medical Centre Ljubljana · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Tick-borne Encephalitis

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2014-09-01
• Primary completion: 2020-09-01
• Completion: 2020-09-01
• First posted: 2015-06-04
• Last updated: 2018-10-16

Locations

1 site across 1 country: Slovenia