NCT02145754CompletedNot Applicable
Comparison of Two Culture Media for Cultivation of Borrelia Burgdorferi Sensu Lato
University Medical Centre Ljubljana2 sites in 1 country235 target enrollmentStarted: July 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 235
- Locations
- 2
- Primary Endpoint
- Detection of Borrelia Burgdorferi Sensu Lato by Microscopy in Dark Field (Positive vs. Negative)
Study Overview
Brief Summary
The main purpose of this study is to compare effectiveness of two different culture media for cultivation of Borrelia burgdorferi sensu lato from skin specimens obtained from patients with erythema migrans.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •erythema migrans in patients > 18 years
Exclusion Criteria
- •pregnancy or lactation
- •taking antibiotic with antiborrelial activity within 10 days
- •erythema migrans localized on face or neck
- •Each patient (235 subjects) provided two skin samples (470 skin samples).
Outcomes
Primary Outcomes
Detection of Borrelia Burgdorferi Sensu Lato by Microscopy in Dark Field (Positive vs. Negative)
Time Frame: weekly examination during 9 weeks of cultivating for individual specimen
number of erythema migrans skin samples with Borrelia Burgdorferi sensu lato detected by Microscopy in Dark Field
Secondary Outcomes
No secondary outcomes reported
Investigators
Franc Strle
MD, PhD
University Medical Centre Ljubljana
Study Sites (2)
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