Tick-borne Encephalitis and Possible Borrelial Serology

NCT03958058 | Completed

• 1 other identifier: TBE-LB observational
• Study Type: observational
• Target: 690
• Locations: 1 country
• Sites: 1

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.

Conditions

Tick Borne Encephalitis; Lyme Disease

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Anti-borrelial antibiotic therapy

Drug: Anti-borrelial antibiotic therapy

No antibiotics

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.

Interventions

Anti-borrelial antibiotic therapy DRUG

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.

Anti-borrelial antibiotic therapy

No antibiotic. OTHER

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.

No antibiotics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with tick-borne encephalitis.

You may qualify if:

• 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)

You may not qualify if:

• Lyme borreliosis in the past

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead
• University of Ljubljana School of Medicine, Slovenia: collaborator

Study Sites (1)

University Medical Center Ljubljana

Ljubljana, Slovenia

Location

MeSH Terms

Conditions

Encephalitis, Tick-Borne; Lyme Disease

Condition Hierarchy (Ancestors)

Encephalitis, Arbovirus; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infections; Infectious Encephalitis; Arbovirus Infections; Vector Borne Diseases; Tick-Borne Diseases; Virus Diseases; RNA Virus Infections; Flavivirus Infections; Flaviviridae Infections; Encephalitis; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Borrelia Infections; Spirochaetales Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: May 21, 2019
• Study Start: January 1, 2007
• Primary Completion: December 31, 2013
• Study Completion: December 31, 2013
• Last Updated: May 21, 2019

Record last verified: 2019-05

Locations

SL (1)