- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02463942
Tick-borne Encephalitis and Positive Borrelial Antibodies (TBE-LB2014)
Management of Patients With Tick-borne Encephalitis and Positive Anti-Lyme Borreliae Antibody Results
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Franc Strle, MD, PhD
- Phone Number: +386 1 5222610
- Email: franc.strle@kclj.si
Study Contact Backup
- Name: Daša Stupica, MD, PhD
- Phone Number: +386 1 5222110
- Email: dasa.stupica@kclj.si
Study Locations
-
-
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Ljubljana, Slovenia, 1525
- Recruiting
- UMC Ljubljana, Department of Infectious Diseases
-
Contact:
- Daša Stupica, MD, PhD
- Phone Number: +386 1 522 2110
- Email: dasa.stupica@kclj.si
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Contact:
- Franc Strle, MD, PhD
- Phone Number: +386 1 522 2610
- Email: franc.strle@kclj.si
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Principal Investigator:
- Daša Stupica, MD, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
Beside symptomatic therapy, patients will receive oral Doxycycline 100 mg, Doxy® twice daily.
|
Other: 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.
|
Subjects will be asked to answer a questionnaire asking about the presence and frequency of nonspecific symptoms such as headache, fatigue, arthralgia, myalgia.
Patients will receive symptomatic therapy with antipyretics, analgetics, antiemetics, and parenteral hydration: metamizole, Analgin®, paracetamol, Lekadol®, thiethylperazine, Kytril®, saline.
|
Other: 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. |
Subjects will be asked to answer a questionnaire asking about the presence and frequency of nonspecific symptoms such as headache, fatigue, arthralgia, myalgia.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Frequency of nonspecific symptoms such as headache, fatigue, arthralgia, myalgia
Time Frame: one year
|
one year
|
Objective manifestations of Lyme borreliosis
Time Frame: one year
|
one year
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Encephalitis, Arbovirus
- Encephalitis, Viral
- Central Nervous System Viral Diseases
- Central Nervous System Infections
- Infectious Encephalitis
- Arbovirus Infections
- Vector Borne Diseases
- Flavivirus Infections
- Flaviviridae Infections
- Tick-Borne Diseases
- Encephalitis
- Encephalitis, Tick-Borne
- Anti-Infective Agents
- Anti-Bacterial Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Doxycycline
Other Study ID Numbers
- TBE-LB2014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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