Tick-borne Encephalitis and Positive Borrelial Antibodies

NCT02463942 | Unknown

• 1 other identifier: TBE-LB2014
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Tick-borne Encephalitis

Outcome Measures

Primary Outcomes (2)

• Objective manifestations of Lyme borreliosis

  one year

• Frequency of nonspecific symptoms such as headache, fatigue, arthralgia, myalgia

  one year

Study Arms (3)

Doxycycline, Doxy®

ACTIVE COMPARATOR

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.

Drug: Doxycycline

No antibiotics

OTHER

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.

Drug: Symptomatic therapy; Other: Questionnaire

Healthy controls

OTHER

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.

Other: Questionnaire

Interventions

Doxycycline DRUG

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

Doxycycline, Doxy®

Symptomatic therapy DRUG

Patients will receive symptomatic therapy with antipyretics, analgetics, antiemetics, and parenteral hydration: metamizole, Analgin®, paracetamol, Lekadol®, thiethylperazine, Kytril®, saline.

No antibiotics

Questionnaire OTHER

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

Healthy controls; No antibiotics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead
• University of Ljubljana School of Medicine, Slovenia: collaborator

Study Sites (1)

UMC Ljubljana, Department of Infectious Diseases

Ljubljana, 1525, Slovenia

RECRUITING

MeSH Terms

Conditions

Encephalitis, Tick-Borne

Interventions

Doxycycline; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Encephalitis, Arbovirus; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infections; Infectious Encephalitis; Arbovirus Infections; Vector Borne Diseases; Tick-Borne Diseases; Virus Diseases; RNA Virus Infections; Flavivirus Infections; Flaviviridae Infections; Encephalitis; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Daša Stupica, MD, PhD

CONTACT

+386 1 5222110; dasa.stupica@kclj.si

Franc Strle, MD, PhD

CONTACT

+386 1 5222610; franc.strle@kclj.si

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: July 20, 2014
• First Posted: June 4, 2015
• Study Start: September 1, 2014
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: October 16, 2018

Record last verified: 2018-05

Locations

SL (1)