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Trial record 9 of 30 for:    lyme AND Skin

Culture Media for Borrelia Burgdorferi Sensu Lato

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ClinicalTrials.gov Identifier: NCT02145754
Recruitment Status : Completed
First Posted : May 23, 2014
Results First Posted : June 30, 2015
Last Update Posted : June 30, 2015
Sponsor:
Collaborator:
University of Ljubljana School of Medicine, Slovenia
Information provided by (Responsible Party):
Franc Strle, University Medical Centre Ljubljana

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Erythema Migrans
Interventions Other: MKP media
Other: BSK-H media
Enrollment 235
Recruitment Details  
Pre-assignment Details  
Arm/Group Title MKP Media Versus BSK-H Media
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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

Period Title: Overall Study
Started 235
Completed 235
Not Completed 0
Arm/Group Title MKP Media Versus BSK-H Media
Hide Arm/Group Description

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 Number of Baseline Participants 235
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 235 participants
<=18 years
0
   0.0%
Between 18 and 65 years
158
  67.2%
>=65 years
77
  32.8%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 235 participants
57
(21 to 93)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 235 participants
Female
141
  60.0%
Male
94
  40.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Slovenia Number Analyzed 235 participants
235
1.Primary Outcome
Title Detection of Borrelia Burgdorferi Sensu Lato by Microscopy in Dark Field (Positive vs. Negative)
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Each participant provided two skin samples for analysis, one sample was cultivated in MKP, the other in BSK-H media.
Arm/Group Title MKP Media Versus BSK-H Media
Hide Arm/Group Description:

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 Number of Participants Analyzed 235
Measure Type: Number
Unit of Measure: culture-positive skin samples
MKP media 102
BSK-H media 59
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MKP Media Versus BSK-h Media
Hide Arm/Group Description

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

All-Cause Mortality
MKP Media Versus BSK-h Media
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
MKP Media Versus BSK-h Media
Affected / at Risk (%)
Total   0/235 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
MKP Media Versus BSK-h Media
Affected / at Risk (%)
Total   0/235 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Daša Stupica
Organization: University Medical center Ljubljana, Infectious Diseases Department
Phone: +386 1 522 21 10
Responsible Party: Franc Strle, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT02145754     History of Changes
Other Study ID Numbers: MKP,BSK-0613
First Submitted: June 24, 2013
First Posted: May 23, 2014
Results First Submitted: January 14, 2015
Results First Posted: June 30, 2015
Last Update Posted: June 30, 2015