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Tick-borne Encephalitis and Borrelial Antibodies in Serum

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ClinicalTrials.gov Identifier: NCT03956446
Recruitment Status : Recruiting
First Posted : May 20, 2019
Last Update Posted : May 20, 2019
Sponsor:
Collaborator:
University of Ljubljana School of Medicine, Slovenia
Information provided by (Responsible Party):
Daša Stupica, University Medical Centre Ljubljana

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Antibiotic Therapy for Patients With Tick-borne Encephalitis and Borrelial Antibodies in Serum
Actual Study Start Date : September 1, 2014
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020


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.

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

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. Questionnaire 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.

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.




Primary Outcome Measures :
  1. Number of patients with objective manifestations of Lyme borreliosis [ Time Frame: one year ]
    At each visit physical examination will be performed and clinical signs indicating objective manifestations of Lyme borreliosis, such as erythema migrans, will be searched for.

  2. 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
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.

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): NCT03956446


Contacts
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Contact: Daša Stupica, MD PhD +386 31 689324 dasa.stupica@kclj.si
Contact: Maša Velušček, MD +38631332904 masa.veluscek@kclj.si

Locations
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Slovenia
University Medical Center Ljubljana Recruiting
Ljubljana, Slovenia
Contact: Daša Stupica, MD, PhD    +386 31 689 324    dasa.stupica@kclj.si   
Contact: Maša Velušček, MD    +386 1 522 21 10    masa.veluscek@kclj.si   
Sponsors and Collaborators
University Medical Centre Ljubljana
University of Ljubljana School of Medicine, Slovenia
Investigators
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Principal Investigator: Daša Stupica, MD PhD University Medical Centre Ljubljana

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Responsible Party: Daša Stupica, Prinicipal Investigator, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT03956446     History of Changes
Other Study ID Numbers: TBE-BB prospect
First Posted: May 20, 2019    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Antibodies
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents