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

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ClinicalTrials.gov Identifier: NCT02463942

Recruitment Status : Unknown

Verified May 2018 by Franc Strle, University Medical Centre Ljubljana.
Recruitment status was: Recruiting

First Posted : June 4, 2015

Last Update Posted : October 16, 2018

Sponsor:

Collaborator:

University of Ljubljana School of Medicine, Slovenia

Information provided by (Responsible Party):

Franc Strle, University Medical Centre Ljubljana

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Tick-borne Encephalitis	Drug: Doxycycline Drug: Symptomatic therapy Other: Questionnaire	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	100 participants
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
Study Start Date :	September 2014
Estimated Primary Completion Date :	September 2020
Estimated Study Completion Date :	September 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Lyme disease

MedlinePlus related topics: Encephalitis

Drug Information available for: Doxycycline Doxycycline monohydrate Doxycycline hyclate Doxycycline calcium

Genetic and Rare Diseases Information Center resources: Tick-borne Encephalitis

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
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

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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

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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

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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

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Responsible Party:	Franc Strle, MD, PhD, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier:	NCT02463942
Other Study ID Numbers:	TBE-LB2014
First Posted:	June 4, 2015 Key Record Dates
Last Update Posted:	October 16, 2018
Last Verified:	May 2018

Additional relevant MeSH terms:

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Encephalitis, Tick-Borne Encephalitis 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 Doxycycline Anti-Bacterial Agents Anti-Infective Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents

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