Tick Borne EncephalitisNCT03958058
Tick-borne Encephalitis and Possible Borrelial Serology
An observational study of Tick Borne Encephalitis and Lyme Disease, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tick Borne Encephalitis, Lyme Disease
- What is being tested?
- Anti-borrelial antibiotic therapy and No antibiotic.
- Type of treatment
- Pill or oral medicine
- How many people
- 690 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Jan 2007to 31 Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with tick-borne encephalitis.
Who may be able to join
- 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)
Who cannot join
- Lyme borreliosis in the past
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tick-Borne Encephalitis Virus and Lyme Borreliae Causing Coillness, Coinfection, or Just Coincidence. A Prospective Observational Study
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
- Being tested
- Anti-borrelial antibiotic therapy, No antibiotic.
- Medical subject headings
- Encephalitis, Tick-Borne, Lyme Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-borrelial antibiotic therapyDrug
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Anti-borrelial antibiotic therapy | Not described Receives: 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. Receives: Other: No antibiotic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start1 Jan 2007
- Primary completion31 Dec 2013
- Study completion31 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tick Borne EncephalitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 690 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ljubljana School of Medicine, Slovenia
- Responsible party
- Principal investigator, Daša Stupica, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03958058
- Sponsor's protocol ID
- TBE-LB observational
- Status last verified
- May 2019
- First submitted
- 17 May 2019
- Last updated
- 21 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tick-Borne Encephalitis Virus and Lyme Borreliae Causing Coillness, Coinfection, or Just Coincidence. A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03958058
- Acronym / sponsor ID
- TBE-LB observational
- Conditions
- Tick Borne Encephalitis, Lyme Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 690 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Collaborators
- University of Ljubljana School of Medicine, Slovenia
- Study start
- 1 Jan 2007 (actual)
- Primary completion
- 31 Dec 2013 (actual)
- Study completion
- 31 Dec 2013 (actual)
- First posted
- 21 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anti-borrelial antibiotic therapy | – | Drug: Anti-borrelial antibiotic therapy |
| No antibiotics | – | Other: No antibiotic.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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with tick-borne encephalitis.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- Lyme borreliosis in the past
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-borrelial antibiotic therapyBeside 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. | Drug | Anti-borrelial antibiotic therapy |
| No antibiotic.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 antibiotics |
Primary outcome
Number of patients with objective manifestations of Lyme borreliosis
Time frame: up to 12 months follow-up
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.
Frequency of nonspecific symptoms such as headache, fatigue, arthralgia, myalgia
Time frame: up to 12 months follow-up
At each visit patients were asked to report the presence of nonspecific symptoms.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tick Borne Encephalitis and Lyme Disease, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with objective manifestations of Lyme borreliosis (time frame: up to 12 months follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2019.