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Clinical Trials/NCT02145754
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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Franc Strle

MD, PhD

University Medical Centre Ljubljana

Study Sites (2)

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