Clinical Trial: Tick-borne Encephalitis and Positive Borrelial Antibodies
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
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.
Detailed Summary:
Sponsor: University Medical Centre Ljubljana
Current Primary Outcome:
- Objective manifestations of Lyme borreliosis [ Time Frame: one year ]
- Frequency of nonspecific symptoms such as headache, fatigue, arthralgia, myalgia [ Time Frame: one year ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: University Medical Centre Ljubljana
Dates:
Date Received: July 20, 2014
Date Started: September 2014
Date Completion: September 2019
Last Updated: May 11, 2016
Last Verified: May 2016
