An observational study in Tick Borne Encephalitis and Lyme Disease, sponsored by University Medical Centre Ljubljana. Completed at 1 site in Slovenia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-21.
Sponsored by University Medical Centre Ljubljana · 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.
51 studies on the registry are indexed under Encephalitis, Tick-Borne; 9 are open to participants now.
This study's enrollment of 690 is above the median of 500 across 11 observational studies indexed under Encephalitis, Tick-Borne.
Browse Encephalitis, Tick-Borne studies →University Medical Centre Ljubljana is the lead sponsor of 296 studies on the registry; 72 are open to participants now.
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Adult patients with tick-borne encephalitis.
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Exclusion Criteria:
Drug: Anti-borrelial antibiotic therapy
Patients who received symptomatic therapy (paracetamol, Lekadol®, granisetron, Kytril®, metamizol, Analgin®, parenteral hydration with saline). Patients reported the presence of nonspecific symptoms such as headache, fatigue, arthralgia, myalgia.
Other: No antibiotic.
Beside symptomatic therapy, patients received oral doxycycline 100 mg (Doxy®) twice daily or ceftriaxone 2 g (Lendacin®) once daily for 14 days. Antibiotic therapy was left to the discretion of treating physicians. Patients reported the presence of nonspecific symptoms such as headache, fatigue, arthralgia, myalgia.
Patients who received symptomatic therapy (paracetamol, Lekadol®, granisetron, Kytril®, metamizol, Analgin®, parenteral hydration with saline). Patients reported the presence of nonspecific symptoms such as headache, fatigue, arthralgia, myalgia.
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.
Time frame: up to 12 months follow-up
Frequency of nonspecific symptoms such as headache, fatigue, arthralgia, myalgia
At each visit patients were asked to report the presence of nonspecific symptoms.
Time frame: up to 12 months follow-up
Ran from Jan 2007 to primary completion in Dec 2013, 83 months.
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This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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