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NCT02145754 Clinical Trial

Culture Media for Borrelia Burgdorferi Sensu Lato

Erythema Migrans Clinical Trial

Official title:
Comparison of Two Culture Media for Cultivation of Borrelia Burgdorferi Sensu Lato

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02145754
Other study ID # MKP,BSK-0613
Secondary ID
Status Completed
Phase N/A
First received June 24, 2013
Last updated June 29, 2015
Start date July 2013

Study information
Verified date June 2015
Source University Medical Centre Ljubljana
Contact n/a
Is FDA regulated No
Health authority Slovenia: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 235
Est. completion date
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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).

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Other:
• MKP media
one half of skin specimen was put in MKP media
• BSK-H media
one half of skin specimen was put in BSK-H media

Locations
Country Name City State
Slovenia UMC Ljubljana, Department of Infectious Diseases Ljubljana

Sponsors (2)
Lead Sponsor Collaborator
University Medical Centre Ljubljana University of Ljubljana School of Medicine, Slovenia

Country where clinical trial is conducted

Slovenia, 

Outcome
Type Measure Description Time frame Safety issue
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 weekly examination during 9 weeks of cultivating for individual specimen No
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