Tick-borne Encephalitis and Positive Borrelial Antibodies (TBE-LB2014)

University Medical Centre Ljubljana

Status: Unknown

Conditions: Tick-borne Encephalitis

Treatments: Drug: Symptomatic therapy; Drug: Doxycycline; Other: Questionnaire

Study type: Interventional

Funder types: Other

Identifiers

NCT02463942

TBE-LB2014

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 3 patient groups

Doxycycline, Doxy®

Active Comparator group

Description:

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.

Treatment:

Drug: Doxycycline

No antibiotics

Other group

Description:

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.

Treatment:

Other: Questionnaire

Drug: Symptomatic therapy

Healthy controls

Other group

Description:

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.

Treatment:

Other: Questionnaire