Trial Outcomes & Findings for Culture Media for Borrelia Burgdorferi Sensu Lato (NCT NCT02145754)

Results Overview

number of erythema migrans skin samples with Borrelia Burgdorferi sensu lato detected by Microscopy in Dark Field

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

235 participants

Primary outcome timeframe

weekly examination during 9 weeks of cultivating for individual specimen

Results posted on

2015-06-30

Participant milestones
Measure	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
Overall Study STARTED	235
Overall Study COMPLETED	235
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Culture Media for Borrelia Burgdorferi Sensu Lato

Baseline characteristics by cohort
Measure	MKP Media Versus BSK-H Media n=235 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	158 Participants n=5 Participants
Age, Categorical >=65 years	77 Participants n=5 Participants
Age, Continuous	57 years n=5 Participants
Sex: Female, Male Female	141 Participants n=5 Participants
Sex: Female, Male Male	94 Participants n=5 Participants
Region of Enrollment Slovenia	235 participants n=5 Participants

Timeframe: 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.

number of erythema migrans skin samples with Borrelia Burgdorferi sensu lato detected by Microscopy in Dark Field

Outcome measures
Measure	MKP Media Versus BSK-H Media n=235 Participants 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
Detection of Borrelia Burgdorferi Sensu Lato by Microscopy in Dark Field (Positive vs. Negative) MKP media	102 culture-positive skin samples
Detection of Borrelia Burgdorferi Sensu Lato by Microscopy in Dark Field (Positive vs. Negative) BSK-H media	59 culture-positive skin samples

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

University Medical center Ljubljana, Infectious Diseases Department

Phone: +386 1 522 21 10