Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03958058
Study type Observational
Source University Medical Centre Ljubljana
Contact
Status Completed
Phase
Start date January 1, 2007
Completion date December 31, 2013

See also
  Status Clinical Trial Phase
Completed NCT01207739 - Persistent Lyme Empiric Antibiotic Study Europe Phase 4
Terminated NCT04577053 - PEMF Therapy to Treat Lingering Symptoms of Lyme Disease After Treatment With Antibiotics N/A
Completed NCT04867473 - Feasibility of Teleyoga for Treatment of Lyme Disease N/A
Recruiting NCT04038346 - Symptomatic Management of Lyme Arthritis Phase 3
Completed NCT01143558 - Searching for Persistence of Infection in Lyme Disease Early Phase 1
Withdrawn NCT04318925 - Evaluation and Follow-up of People With Tick-borne Diseases
Terminated NCT03581279 - Detection of Borrelia Bacteria in Early Stage Lyme Borreliosis Using the T2Lyme Panel N/A
Enrolling by invitation NCT05041595 - Lyme Disease Diagnostic Assay - Collection of Whole Blood
Recruiting NCT03981874 - Peripheral Facial Paralysis Sequelae in Lyme Disease Among Children N/A
Recruiting NCT03963635 - Novel Diagnostics for Early Lyme Disease
Terminated NCT03084614 - CD8 Reactivity to Microorganisms in Blood and Breast Milk
Recruiting NCT04835792 - Biomarker Study of Previously Treated Lyme Disease Volunteers in Comparison to Healthy Volunteers
Recruiting NCT06397794 - Navigating Pregnancy and Parenthood With Lyme Disease
Recruiting NCT04148222 - A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Lyme Disease
Terminated NCT03201042 - Lyme Test Indication Combinations (LyTIC) Study
Completed NCT01368341 - Comparing 3 Antibiotic Regimes for Erythema Migrans in General Practice Phase 4
Terminated NCT00958139 - Passive Prophylaxis of Lyme Disease Using Permethrin Treated Clothes Phase 3
Recruiting NCT00001539 - A Comprehensive Clinical, Microbiological and Immunological Assessment of Patients With Suspected Post Treatment Lyme Disease Syndrome and Selected Control Populations
Recruiting NCT03501407 - Understanding Tick-borne Diseases
Completed NCT04422314 - ImmuneSense Lyme Study