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Trial record 9 of 30 for:    lyme AND Skin

Culture Media for Borrelia Burgdorferi Sensu Lato

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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

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.

Condition or disease Intervention/treatment Phase
Erythema Migrans Other: MKP media Other: BSK-H media Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 235 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparison of Two Culture Media for Cultivation of Borrelia Burgdorferi Sensu Lato
Study Start Date : July 2013
Actual Primary Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lyme Disease

Arm Intervention/treatment
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
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




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02145754


Locations
Slovenia
UMC Ljubljana, Department of Infectious Diseases
Ljubljana, Slovenia, 1525
Sponsors and Collaborators
University Medical Centre Ljubljana
University of Ljubljana School of Medicine, Slovenia
Investigators
Study Director: Franc Strle, MD, PhD UMC Ljubljana
Principal Investigator: Eva Ruzic-Sabljic, MD, PhD University of Ljubljana School of Medicine, Slovenia

Responsible Party: Franc Strle, MD, PhD, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT02145754     History of Changes
Other Study ID Numbers: MKP,BSK-0613
First Posted: May 23, 2014    Key Record Dates
Results First Posted: June 30, 2015
Last Update Posted: June 30, 2015
Last Verified: June 2015

Keywords provided by Franc Strle, University Medical Centre Ljubljana:
erythema migrans
Lyme borreliosis
Borrelia burgdorferi
skin culture
culture media

Additional relevant MeSH terms:
Lyme Disease
Skin Diseases
Skin Diseases, Bacterial
Skin Diseases, Infectious
Erythema
Erythema Chronicum Migrans
Glossitis, Benign Migratory
Borrelia Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Tick-Borne Diseases
Spirochaetales Infections
Infection
Glossitis
Tongue Diseases
Mouth Diseases
Stomatognathic Diseases