Comparison of Two Culture Media for Cultivation of Borrelia Burgdorferi Sensu Lato
| Registry | NCT02145754 |
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| Status | Completed |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, parallel, masking: none, diagnostic |
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| Enrollment | 235 (Actual) |
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| Sponsor | University Medical Centre Ljubljana (Other); collaborators: University of Ljubljana School of Medicine, Slovenia |
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| Conditions | Erythema Migrans |
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| Interventions | MKP media, BSK-H media (Other) |
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| Dates | start 2013-07-01, primary completion 2014-12-01, first posted 2014-05-23, last updated 2015-06-30 |
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| Locations | 1 site in Slovenia |
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-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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
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| MKP media versus BSK-H media | Active comparator | Other: MKP media; Other: BSK-H media | 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 |
- MKP media (Other): one half of skin specimen was put in MKP media
- BSK-H media (Other): one half of skin specimen was put in BSK-H media
+Outcome measures
Primary outcomes
- Detection of Borrelia Burgdorferi Sensu Lato by Microscopy in Dark Field (Positive vs. Negative) [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
+Eligibility
Sex: All, ages: 18 Years to any
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).
+Posted results
Participant flow
| Milestone | MKP Media Versus BSK-H Media |
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| Started | 235 |
| Completed | 235 |
| Not completed | 0 |
Outcome results
- Detection of Borrelia Burgdorferi Sensu Lato by Microscopy in Dark Field (Positive vs. Negative) (Primary), Number, culture-positive skin samples: MKP Media Versus BSK-H Media 102
Adverse events
| Arm | Deaths | Serious adverse events | Other adverse events |
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| MKP Media Versus BSK-h Media | 0 | 0/235 (0.0%) | 0/235 (0.0%) |
+Locations (1)
| Facility | City | Country | Status |
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| UMC Ljubljana, Department of Infectious Diseases | Ljubljana | Slovenia | |
+Investigators