Erythema Migrans
Conditions
Keywords
erythema migrans, Lyme borreliosis, Borrelia burgdorferi, skin culture, culture media
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.
Interventions
OTHERMKP media
one half of skin specimen was put in MKP media
OTHERBSK-H media
one half of skin specimen was put in BSK-H media
Sponsors
University of Ljubljana School of Medicine, Slovenia
University Medical Centre Ljubljana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Slovenia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 235 |
| Total | 235 |
Baseline characteristics
| Characteristic | MKP Media Versus BSK-H Media |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 77 Participants |
| Age, Categorical Between 18 and 65 years | 158 Participants |
| Age, Continuous | 57 years |
| Region of Enrollment Slovenia | 235 participants |
| Sex: Female, Male Female | 141 Participants |
| Sex: Female, Male Male | 94 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 235 |
| serious Total, serious adverse events | 0 / 235 |
Outcome results
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
Time frame: weekly examination during 9 weeks of cultivating for individual specimen
Population: Each participant provided two skin samples for analysis, one sample was cultivated in MKP, the other in BSK-H media.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MKP Media Versus BSK-H Media | Detection of Borrelia Burgdorferi Sensu Lato by Microscopy in Dark Field (Positive vs. Negative) | MKP media | 102 culture-positive skin samples |
| MKP Media Versus BSK-H Media | Detection of Borrelia Burgdorferi Sensu Lato by Microscopy in Dark Field (Positive vs. Negative) | BSK-H media | 59 culture-positive skin samples |