Lyme Disease Clinical Trial
Official title:
Tick-Borne Encephalitis Virus and Lyme Borreliae Causing Coillness, Coinfection, or Just Coincidence. A Prospective Observational Study
Verified date | May 2019 |
Source | University Medical Centre Ljubljana |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 690 |
Est. completion date | December 31, 2013 |
Est. primary completion date | December 31, 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Slovenia | University Medical Center Ljubljana | Ljubljana |
Lead Sponsor | Collaborator |
---|---|
University Medical Centre Ljubljana | University of Ljubljana School of Medicine, Slovenia |
Slovenia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients with objective manifestations of Lyme borreliosis | At each visit physical examination was performed and clinical signs indicating objective manifestations of Lyme borreliosis, such as erythema migrans, were searched for and documented. | up to 12 months follow-up | |
Primary | Frequency of nonspecific symptoms such as headache, fatigue, arthralgia, myalgia | At each visit patients were asked to report the presence of nonspecific symptoms. | up to 12 months follow-up |
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