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Tick-borne Encephalitis and Borrelial Antibodies in Serum

Primary Purpose

Tick Borne Encephalitis

Status
Recruiting
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
Doxycycline
Symptomatic therapy
Questionnaire
Sponsored by
University Medical Centre Ljubljana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tick Borne Encephalitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University Medical Center LjubljanaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Other

Other

Arm Label

Doxycycline, Doxy®

No antibiotics

Healthy controls

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Number of patients with objective manifestations of Lyme borreliosis
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.
Frequency of nonspecific symptoms such as headache, fatigue, arthralgia, myalgia

Secondary Outcome Measures

Full Information

First Posted
May 15, 2019
Last Updated
May 16, 2022
Sponsor
University Medical Centre Ljubljana
Collaborators
University of Ljubljana School of Medicine, Slovenia
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1. Study Identification

Unique Protocol Identification Number
NCT03956446
Brief Title
Tick-borne Encephalitis and Borrelial Antibodies in Serum
Official Title
Antibiotic Therapy for Patients With Tick-borne Encephalitis and Borrelial Antibodies in Serum
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2014 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Centre Ljubljana
Collaborators
University of Ljubljana School of Medicine, Slovenia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tick Borne Encephalitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Doxycycline, Doxy®
Arm Type
Active Comparator
Arm Description
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.
Arm Title
No antibiotics
Arm Type
Other
Arm Description
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.
Arm Title
Healthy controls
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Doxycycline
Intervention Description
Beside symptomatic therapy, patients will receive oral Doxycycline 100 mg, Doxy® twice daily.
Intervention Type
Drug
Intervention Name(s)
Symptomatic therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Questionnaire
Intervention Description
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 Measure Information:
Title
Number of patients with objective manifestations of Lyme borreliosis
Description
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.
Time Frame
one year
Title
Frequency of nonspecific symptoms such as headache, fatigue, arthralgia, myalgia
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daša Stupica, MD PhD
Phone
+386 31 689324
Email
dasa.stupica@kclj.si
First Name & Middle Initial & Last Name or Official Title & Degree
Maša Velušček, MD
Phone
+38631332904
Email
masa.veluscek@kclj.si
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daša Stupica, MD PhD
Organizational Affiliation
University Medical Centre Ljubljana
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Ljubljana
City
Ljubljana
Country
Slovenia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daša Stupica, MD, PhD
Phone
+386 31 689 324
Email
dasa.stupica@kclj.si
First Name & Middle Initial & Last Name & Degree
Maša Velušček, MD
Phone
+386 1 522 21 10
Email
masa.veluscek@kclj.si

12. IPD Sharing Statement

Learn more about this trial

Tick-borne Encephalitis and Borrelial Antibodies in Serum

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