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Culture Media for Borrelia Burgdorferi Sensu Lato

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE June 24, 2013
First Posted Date  ICMJE May 23, 2014
Results First Submitted Date  ICMJE January 14, 2015
Results First Posted Date  ICMJE June 30, 2015
Last Update Posted Date June 30, 2015
Study Start Date  ICMJE July 2013
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2015)
Detection of Borrelia Burgdorferi Sensu Lato by Microscopy in Dark Field (Positive vs. Negative) [ Time Frame: 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
Original Primary Outcome Measures  ICMJE
 (submitted: May 20, 2014)
Detection of Borrelia Burgdorferi Sensu Lato by Microscopy in Dark Field (Positive vs. Negative) [ Time Frame: weekly examination during 9 weeks of cultivating for individual specimen ]
Change History Complete list of historical versions of study NCT02145754 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Culture Media for Borrelia Burgdorferi Sensu Lato
Official Title  ICMJE Comparison of Two Culture Media for Cultivation of Borrelia Burgdorferi Sensu Lato
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Erythema Migrans
Intervention  ICMJE
  • Other: MKP media
    one half of skin specimen was put in MKP media
  • Other: BSK-H media
    one half of skin specimen was put in BSK-H media
Study Arms  ICMJE Active Comparator: MKP media versus BSK-H media
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
Interventions:
  • Other: MKP media
  • Other: BSK-H media
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 29, 2015)
235
Original Estimated Enrollment  ICMJE
 (submitted: May 20, 2014)
150
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Slovenia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02145754
Other Study ID Numbers  ICMJE MKP,BSK-0613
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Franc Strle, University Medical Centre Ljubljana
Study Sponsor  ICMJE University Medical Centre Ljubljana
Collaborators  ICMJE University of Ljubljana School of Medicine, Slovenia
Investigators  ICMJE
Study Director: Franc Strle, MD, PhD UMC Ljubljana
Principal Investigator: Eva Ruzic-Sabljic, MD, PhD University of Ljubljana School of Medicine, Slovenia
PRS Account University Medical Centre Ljubljana
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP