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

Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Slovenia
University Medical Center Ljubljana
RECRUITING
Ljubljana
Contact Information
Primary
Daša Stupica, MD PhD
dasa.stupica@kclj.si
+386 31 689324
Backup
Maša Velušček, MD
masa.veluscek@kclj.si
+38631332904
Time Frame
Start Date: 2014-09-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 80
Treatments
Active_comparator: Doxycycline, Doxy®
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.
Other: No antibiotics
Patients will receive symptomatic therapy (paracetamol, Lekadol®, granisetron, Kytril®, metamizol, Analgin®, parenteral hydration with saline). Patients will answer a questionnaire asking about the presence and frequency of nonspecific symptoms such as headache, fatigue, arthralgia, myalgia.
Other: Healthy controls
Patients will be asked to refer a spouse to serve as a control. If unmarried they will be asked to refer a family member or a friend of +/- 5 years to serve as a control. Control subjects will be asked to answer a questionnaire asking about the presence and frequency of nonspecific symptoms such as headache, fatigue, arthralgia, myalgia.
Sponsors
Collaborators: University of Ljubljana School of Medicine, Slovenia
Leads: University Medical Centre Ljubljana

This content was sourced from clinicaltrials.gov