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| Name | Class |
|---|---|
| University of Ljubljana School of Medicine, Slovenia | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MKP media versus BSK-H media | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MKP media | Other | one half of skin specimen was put in MKP media |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | weekly examination during 9 weeks of cultivating for individual specimen |
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Inclusion Criteria:
Exclusion Criteria:
Each patient (235 subjects) provided two skin samples (470 skin samples).
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| Name | Affiliation | Role |
|---|---|---|
| Franc Strle, MD, PhD | UMC Ljubljana | Study Director |
| Eva Ruzic-Sabljic, MD, PhD | University of Ljubljana School of Medicine, Slovenia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMC Ljubljana, Department of Infectious Diseases | Ljubljana | 1525 | Slovenia |
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| ID | Title | Description |
|---|---|---|
| FG000 | MKP Media Versus BSK-H Media | cultivation of Borrelia burgdorferi sensu lato (from skin specimens obtained from erythema migrans patients) in MKP media and in BSK-h media MKP media versus BSK-H media |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MKP Media Versus BSK-H Media | cultivation of Borrelia burgdorferi sensu lato (from skin specimens obtained from erythema migrans patients) in MKP media and in BSK-H media MKP media versus BSK-H media |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Each participant provided two skin samples for analysis, one sample was cultivated in MKP, the other in BSK-H media. | Posted | Number | culture-positive skin samples | weekly examination during 9 weeks of cultivating for individual specimen |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MKP Media Versus BSK-h Media | cultivation of Borrelia burgdorferi sensu lato (from skin specimens obtained from erythema migrans patients) in MKP media and in BSK-H media MKP media versus BSK-H media |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daša Stupica | University Medical center Ljubljana, Infectious Diseases Department | +386 1 522 21 10 | dasa.stupica@kclj.si |
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| ID | Term |
|---|---|
| D005929 | Glossitis, Benign Migratory |
| D008193 | Lyme Disease |
| ID | Term |
|---|---|
| D005928 | Glossitis |
| D014060 | Tongue Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| BSK-H media |
| Other |
one half of skin specimen was put in BSK-H media |
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| Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units |
|---|
| Counts |
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| Participants |
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| 0 |
| 235 |
| 0 |
| 235 |
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| D016905 |
| Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D001899 | Borrelia Infections |
| D013145 | Spirochaetales Infections |
| D017282 | Tick-Borne Diseases |
| D000079426 | Vector Borne Diseases |