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Trial record 9 of 30 for:    lyme AND Skin

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

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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    MKP Media Versus BSK-H Media
STARTED   235 
COMPLETED   235 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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


Baseline Measures
   MKP Media Versus BSK-H Media 
Overall Participants Analyzed 
[Units: Participants]
 235 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   158 
>=65 years   77 
Age 
[Units: Years]
Mean (Full Range)
 57 
 (21 to 93) 
Gender 
[Units: Participants]
 
Female   141 
Male   94 
Region of Enrollment 
[Units: Participants]
 
Slovenia   235 


  Outcome Measures

1.  Primary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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
e-mail: dasa.stupica@kclj.si



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