Back to resultsCulture Media for Borrelia Burgdorferi Sensu Lato
Primary Purpose
Erythema Migrans
Status
Completed
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
MKP media
BSK-H media
Sponsored by
About this trial
This is an interventional diagnostic trial for Erythema Migrans focused on measuring erythema migrans, Lyme borreliosis, Borrelia burgdorferi, skin culture, culture media
Eligibility Criteria
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).
Sites / Locations
- UMC Ljubljana, Department of Infectious Diseases
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
MKP media versus BSK-H media
Arm Description
one half of skin specimen obtained from erythema migrans patients was cultivated for Borrelia burgdorferi sensu lato in MKP media and the other half in BSK-H media
Outcomes
Primary Outcome Measures
Detection of Borrelia Burgdorferi Sensu Lato by Microscopy in Dark Field (Positive vs. Negative)
number of erythema migrans skin samples with Borrelia Burgdorferi sensu lato detected by Microscopy in Dark Field
Secondary Outcome Measures
Full Information
NCT ID
NCT02145754
First Posted
June 24, 2013
Last Updated
June 29, 2015
Sponsor
University Medical Centre Ljubljana
Collaborators
University of Ljubljana School of Medicine, Slovenia
1. Study Identification
Unique Protocol Identification Number
NCT02145754
Brief Title
Culture Media for Borrelia Burgdorferi Sensu Lato
Official Title
Comparison of Two Culture Media for Cultivation of Borrelia Burgdorferi Sensu Lato
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Centre Ljubljana
Collaborators
University of Ljubljana School of Medicine, Slovenia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erythema Migrans
Keywords
erythema migrans, Lyme borreliosis, Borrelia burgdorferi, skin culture, culture media
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
235 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MKP media versus BSK-H media
Arm Type
Active Comparator
Arm Description
one half of skin specimen obtained from erythema migrans patients was cultivated for Borrelia burgdorferi sensu lato in MKP media and the other half in BSK-H media
Intervention Type
Other
Intervention Name(s)
MKP media
Intervention Description
one half of skin specimen was put in MKP media
Intervention Type
Other
Intervention Name(s)
BSK-H media
Intervention Description
one half of skin specimen was put in BSK-H media
Primary Outcome Measure Information:
Title
Detection of Borrelia Burgdorferi Sensu Lato by Microscopy in Dark Field (Positive vs. Negative)
Description
number of erythema migrans skin samples with Borrelia Burgdorferi sensu lato detected by Microscopy in Dark Field
Time Frame
weekly examination during 9 weeks of cultivating for individual specimen
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franc Strle, MD, PhD
Organizational Affiliation
UMC Ljubljana
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Eva Ruzic-Sabljic, MD, PhD
Organizational Affiliation
University of Ljubljana School of Medicine, Slovenia
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMC Ljubljana, Department of Infectious Diseases
City
Ljubljana
ZIP/Postal Code
1525
Country
Slovenia
12. IPD Sharing Statement
Learn more about this trial
Culture Media for Borrelia Burgdorferi Sensu Lato
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