Tick-borne Encephalitis and Possible Borrelial Serology
Keywords
Abstract
Dates
Last Verified: | 04/30/2019 |
First Submitted: | 05/16/2019 |
Estimated Enrollment Submitted: | 05/16/2019 |
First Posted: | 05/20/2019 |
Last Update Submitted: | 05/16/2019 |
Last Update Posted: | 05/20/2019 |
Actual Study Start Date: | 12/31/2006 |
Estimated Primary Completion Date: | 12/30/2013 |
Estimated Study Completion Date: | 12/30/2013 |
Condition or disease
Intervention/treatment
Drug: Anti-borrelial antibiotic therapy
Other: No antibiotics
Phase
Arm Groups
Arm | Intervention/treatment |
---|---|
Anti-borrelial antibiotic therapy | Drug: Anti-borrelial antibiotic therapy 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 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 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. |
Eligibility Criteria
Ages Eligible for Study | 18 Years To 18 Years |
Sexes Eligible for Study | All |
Sampling method | Non-Probability Sample |
Accepts Healthy Volunteers | Yes |
Criteria | Inclusion Criteria: - 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) Exclusion Criteria: - Lyme borreliosis in the past |
Outcome
Primary Outcome Measures
1. Number of patients with objective manifestations of Lyme borreliosis [up to 12 months follow-up]
2. Frequency of nonspecific symptoms such as headache, fatigue, arthralgia, myalgia [up to 12 months follow-up]