Tick-borne Encephalitis and Possible Borrelial Serology

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Brief Title

Tick-borne Encephalitis and Possible Borrelial Serology

Official Title

Tick-Borne Encephalitis Virus and Lyme Borreliae Causing Coillness, Coinfection, or Just Coincidence. A Prospective Observational Study

Brief Summary

      In Europe, tick-borne encephalitis (TBE) virus causing TBE is transmitted by the bite of
      Ixodes ricinus tick, which can also transmit Lyme borreliae , the causative agent of Lyme
      borreliosis (LB). Since TBE and LB are both endemic with high incidence rates in Slovenia, we
      should be attentive to the possibility of double infections. Double infections with TBE virus
      and Lyme borreliae were reported to occur rarely even in endemic countries, however reliable
      data on coinfection rates are rather limited. Microbiological diagnosis of TBE virus
      infection is quite straightforward, and there is no specific therapy for TBE available so
      far. This markedly differs from borrelial infection, in which case interpretation of
      serological test results demands more caution, but there is highly efficient antibiotic
      treatment available for LB. This may lead to over prescribing of antibiotics to TBE patients
      with documented borrelial antibodies in serum indicating possible coinfection with Lyme
      borreliae, but missing clinical or microbiological criteria for proven borrelial coinfection.
      Approximately 10% of patients who had been treated appropriately for LB and about one third
      of patients after TBE report nonspecific subjective complaints, such as fatigue, headache,
      arthralgia, and myalgia, termed post-Lyme and post-encephalitic symptoms, respectively. These
      may not be differentiated clearly from nonspecific symptoms occurring with a rather
      substantial incidence also in the general population. A trend of ascribing medically
      unexplained nonspecific subjective symptoms to LB in subjects with positive borrelial
      antibodies in serum puzzles the situation further.

      The aim of this prospective observational study was to assess the proportion and clinical
      implication of proven and possible coinfection with Lyme borreliae in patients with TBE, and
      to evaluate the association between anti-borrelial antibiotic therapy and clinical outcome in
      the subgroup of patients with possible coinfection.
    



Study Type

Observational


Primary Outcome

Number of patients with objective manifestations of Lyme borreliosis


Condition

Tick Borne Encephalitis

Intervention

Anti-borrelial antibiotic therapy

Study Arms / Comparison Groups

 Anti-borrelial antibiotic therapy
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

690

Start Date

January 1, 2007

Completion Date

December 31, 2013

Primary Completion Date

December 31, 2013

Eligibility Criteria

        Inclusion Criteria:

          -  age ≥18 years

          -  admitted between January 2007 and December 2013 at the University Medical Centre
             Ljubljana, Slovenia

          -  tick-borne encephalitis defined according to European criteria (febrile illness with
             symptoms and/or signs of meningitis or meningoencephalitis, cerebrospinal fluid (CSF)
             pleocytosis (>5 × 106 cells/L), and demonstration of acute TBE virus infection (the
             presence of specific tick-borne encephalitis virus IgM and IgG antibodies in serum or
             demonstration of intrathecal production of specific TBE virus IgM and/or IgG
             antibodies in patients previously vaccinated against tick-borne encephalitis)

        Exclusion Criteria:

          -  Lyme borreliosis in the past
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

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Location Countries

Slovenia

Location Countries

Slovenia

Administrative Informations


NCT ID

NCT03958058

Organization ID

TBE-LB observational


Responsible Party

Principal Investigator

Study Sponsor

University Medical Centre Ljubljana

Collaborators

 University of Ljubljana School of Medicine, Slovenia

Study Sponsor

, , 


Verification Date

May 2019