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

This study is currently recruiting participants.
Verified May 2016 by Franc Strle, University Medical Centre Ljubljana
Sponsor:
ClinicalTrials.gov Identifier:
NCT02463942
First Posted: June 4, 2015
Last Update Posted: May 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
University of Ljubljana School of Medicine, Slovenia
Information provided by (Responsible Party):
Franc Strle, University Medical Centre Ljubljana
  Purpose

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.


Condition Intervention
Tick-borne Encephalitis Drug: Doxycycline Drug: Symptomatic therapy Other: Questionnaire

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Management of Patients With Tick-borne Encephalitis and Positive Anti-Lyme Borreliae Antibody Results

Resource links provided by NLM:


Further study details as provided by Franc Strle, University Medical Centre Ljubljana:

Primary Outcome Measures:
  • Objective manifestations of Lyme borreliosis [ Time Frame: one year ]
  • Frequency of nonspecific symptoms such as headache, fatigue, arthralgia, myalgia [ Time Frame: one year ]

Estimated Enrollment: 100
Study Start Date: September 2014
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Doxycycline
Beside symptomatic therapy, patients will receive oral Doxycycline 100 mg, Doxy® twice daily.
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.
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.
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.

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.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02463942


Contacts
Contact: Daša Stupica, MD, PhD +386 1 5222110 dasa.stupica@kclj.si
Contact: Franc Strle, MD, PhD +386 1 5222610 franc.strle@kclj.si

Locations
Slovenia
UMC Ljubljana, Department of Infectious Diseases Recruiting
Ljubljana, Slovenia, 1525
Contact: Daša Stupica, MD, PhD    +386 1 522 2110    dasa.stupica@kclj.si   
Contact: Franc Strle, MD, PhD    +386 1 522 2610    franc.strle@kclj.si   
Principal Investigator: Daša Stupica, MD, PhD         
Sponsors and Collaborators
University Medical Centre Ljubljana
University of Ljubljana School of Medicine, Slovenia
  More Information

Responsible Party: Franc Strle, MD, PhD, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT02463942     History of Changes
Other Study ID Numbers: TBE-LB2014
First Submitted: July 20, 2014
First Posted: June 4, 2015
Last Update Posted: May 12, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Encephalitis
Encephalitis, Tick-Borne
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Encephalitis, Arbovirus
Arbovirus Infections
Virus Diseases
Tick-Borne Diseases
Encephalitis, Viral
Central Nervous System Viral Diseases
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections
Infectious Encephalitis
Central Nervous System Infections
Antibodies
Doxycycline
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents