Investigating tick-borne encephalitis and borrelial antibodies in patients
Antibiotic Therapy for Patients With Tick-borne Encephalitis and Borrelial Antibodies in Serum
NA · University Medical Centre Ljubljana · NCT03956446
This study is testing if giving antibiotics helps patients in Slovenia with tick-borne encephalitis symptoms and positive borrelial antibodies, even if they don't have Lyme disease.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Centre Ljubljana (other) |
| Locations | 1 site (Ljubljana) |
| Trial ID | NCT03956446 on ClinicalTrials.gov |
What this trial studies
This study examines patients in Slovenia who present with symptoms of tick-borne encephalitis and have positive borrelial antibodies in their serum. The researchers aim to determine whether these patients benefit from antibiotic treatment, given that they may not have Lyme neuroborreliosis despite the presence of borrelial antibodies. The study involves administering doxycycline and symptomatic therapy while collecting data through questionnaires. The goal is to clarify treatment protocols for patients with potential double infections.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with clinical signs of tick-borne encephalitis and specific laboratory findings.
Not a fit: Patients who have confirmed Lyme neuroborreliosis or recent borrelial infections will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate treatment protocols for patients with tick-borne encephalitis and reduce unnecessary antibiotic use.
How similar studies have performed: While there is limited data on this specific approach, similar studies have explored the complexities of co-infections and treatment efficacy, indicating a need for further investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years or older * clinical picture compatible with tick-borne encephalitis, * clear cerebrospinal fluid, * cerebrospinal pleocytosis (leucocytes in cerebrospinal fluid \>5 x 106/)L, * positive serum immunoglobulin M (IgM) and immunoglobulin G (IgG) antibodies against tick-borne encephalitis virus, * positive serum IgG antibodies against Lyme borreliae. Exclusion Criteria: * isolation of B.burgdorferi sensu lato from cerebrospinal fluid, * positive intrathecal borrelial antibody production index, * seroconversion of borrelial IgG antibodies, * presence of erythema migrans and/or borrelial lymphocytoma in the last month, * Bannwarth syndrome.
Where this trial is running
Ljubljana
- University Medical Center Ljubljana — Ljubljana, Slovenia (RECRUITING)
Study contacts
- Principal investigator: Daša Stupica, MD PhD — University Medical Centre Ljubljana
- Study coordinator: Daša Stupica, MD PhD
- Email: dasa.stupica@kclj.si
- Phone: +386 31 689324
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Tick Borne Encephalitis