Culture Media for Borrelia Burgdorferi Sensu Lato

Not Applicable

Completed

• Conditions: Erythema Migrans
• Interventions: Other: MKP media; Other: BSK-H media

• Registration Number: NCT02145754
• Lead Sponsor: University Medical Centre Ljubljana

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 available

Study Timeline

• Study First Submitted: 2013-06-24
• Study Start: 2013-07
• Study First Submitted QC: 2014-05-20
• Study First Posted: 2014-05-23
• Primary Completion: 2014-12
• Results First Submitted: 2015-01-14
• Status Verified: 2015-06
• Results First Submitted QC: 2015-06-29
• Last Update Submitted: 2015-06-29
• Results First Posted: 2015-06-30
• Last Update Posted: 2015-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 235

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MKP media versus BSK-H media	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
MKP media versus BSK-H media	MKP 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

Primary Outcome Measures

Name	Time	Method
Detection of Borrelia Burgdorferi Sensu Lato by Microscopy in Dark Field (Positive vs. Negative)	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

Trial Locations

Locations (1)

UMC Ljubljana, Department of Infectious Diseases; 🇸🇮 Ljubljana, Slovenia