An interventional study of MKP media and BSK-H media in Erythema Migrans, sponsored by University Medical Centre Ljubljana. Completed at 1 site in Slovenia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-06-30.
Sponsored by University Medical Centre Ljubljana · Not applicable, Interventional, and Diagnostic
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.
25 studies on the registry are indexed under Glossitis, Benign Migratory; 4 are open to participants now.
This study's enrollment of 235 is above the median of 200 across 13 interventional studies indexed under Glossitis, Benign Migratory.
Browse Glossitis, Benign Migratory studies →University Medical Centre Ljubljana is the lead sponsor of 296 studies on the registry; 72 are open to participants now.
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Exclusion Criteria:
Each patient (235 subjects) provided two skin samples (470 skin samples).
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
Other: MKP media · Other: BSK-H media
one half of skin specimen was put in MKP media
one half of skin specimen was put in BSK-H media
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
Time frame: weekly examination during 9 weeks of cultivating for individual specimen
| Milestone | MKP Media Versus BSK-H Media |
|---|---|
| Started | 235 |
| Completed | 235 |
| Not completed | 0 |
number of erythema migrans skin samples with Borrelia Burgdorferi sensu lato detected by Microscopy in Dark Field
| culture-positive skin samples | MKP Media Versus BSK-H Media |
|---|---|
| MKP media | 102 |
| BSK-H media | 59 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MKP Media Versus BSK-h Media | — | 0/235 (0%) | 0/235 (0%) |
| Age, Categorical(Participants) | MKP Media Versus BSK-H Media |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 158 |
| >=65 years | 77 |
| Age, Continuous(years) | MKP Media Versus BSK-H Media |
|---|---|
| Mean | 57 (21 to 93) |
| Sex: Female, Male(Participants) | MKP Media Versus BSK-H Media |
|---|---|
| Female | 141 |
| Male | 94 |
| Region of Enrollment(participants) | MKP Media Versus BSK-H Media |
|---|---|
| Slovenia | 235 |
The record gives a start of Jul 2013 and a primary completion of Dec 2014. It does not say whether these dates are actual or estimated.
Results were first posted in Jun 2015, 6 months after primary completion.
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This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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