Culture Media for Borrelia Burgdorferi Sensu Lato

NCT ID: NCT02145754

Last Updated: 2015-06-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

235 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Brief Summary

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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

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Conditions

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Erythema Migrans

Keywords

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erythema migrans Lyme borreliosis Borrelia burgdorferi skin culture culture media

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

MKP media

Intervention Type OTHER

one half of skin specimen was put in MKP media

BSK-H media

Intervention Type OTHER

one half of skin specimen was put in BSK-H media

Interventions

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MKP media

one half of skin specimen was put in MKP media

Intervention Type OTHER

BSK-H media

one half of skin specimen was put in BSK-H media

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Ljubljana School of Medicine, Slovenia

OTHER

Sponsor Role collaborator

University Medical Centre Ljubljana

OTHER

Sponsor Role lead

Responsible Party

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Franc Strle

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Franc Strle, MD, PhD

Role: STUDY_DIRECTOR

UMC Ljubljana

Eva Ruzic-Sabljic, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Ljubljana School of Medicine, Slovenia

Locations

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UMC Ljubljana, Department of Infectious Diseases

Ljubljana, , Slovenia

Site Status

Countries

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Slovenia

Other Identifiers

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MKP,BSK-0613

Identifier Type: -

Identifier Source: org_study_id