We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 30 of 64 for:    lyme

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02463942
Recruitment Status : Recruiting
First Posted : June 4, 2015
Last Update Posted : May 12, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

July 20, 2014
June 4, 2015
May 12, 2016
September 2014
September 2018   (Final data collection date for primary outcome measure)
  • Objective manifestations of Lyme borreliosis [ Time Frame: one year ]
  • Frequency of nonspecific symptoms such as headache, fatigue, arthralgia, myalgia [ Time Frame: one year ]
Same as current
Complete list of historical versions of study NCT02463942 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Tick-borne Encephalitis and Positive Borrelial Antibodies
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Tick-borne Encephalitis
  • 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.
  • 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.
  • 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.
    Intervention: Drug: Doxycycline
  • 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.
    Interventions:
    • Drug: Symptomatic therapy
    • Other: Questionnaire
  • 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.

    Intervention: Other: Questionnaire
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
September 2019
September 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
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
 
 
NCT02463942
TBE-LB2014
No
Not Provided
Not Provided
Franc Strle, University Medical Centre Ljubljana
University Medical Centre Ljubljana
University of Ljubljana School of Medicine, Slovenia
Not Provided
University Medical Centre Ljubljana
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP