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
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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 |
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Tick-borne Encephalitis | Drug: Doxycycline Drug: Symptomatic therapy Other: Questionnaire | Not Applicable |
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 |

Arm | Intervention/treatment |
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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.
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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.
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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. |
- Objective manifestations of Lyme borreliosis [ Time Frame: one year ]
- Frequency of nonspecific symptoms such as headache, fatigue, arthralgia, myalgia [ Time Frame: one year ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

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