NCT02145754

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
235

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2013

Completed
7 days until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
11 months until next milestone

First Posted

Study publicly available on registry

May 23, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
7 months until next milestone

Results Posted

Study results publicly available

June 30, 2015

Completed
Last Updated

June 30, 2015

Status Verified

June 1, 2015

Enrollment Period

1.4 years

First QC Date

June 24, 2013

Results QC Date

January 14, 2015

Last Update Submit

June 29, 2015

Conditions

Erythema Migrans

Keywords

erythema migransLyme borreliosisBorrelia burgdorferiskin cultureculture media

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

MKP media versus BSK-H media

ACTIVE COMPARATOR

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 mediaOther: BSK-H media

Interventions

MKP mediaOTHER

one half of skin specimen was put in MKP media

MKP media versus BSK-H media
BSK-H mediaOTHER

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

MKP media versus BSK-H media

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • erythema migrans in patients \> 18 years

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMC Ljubljana, Department of Infectious Diseases

Ljubljana, 1525, Slovenia

Location

MeSH Terms

Conditions

Glossitis, Benign MigratoryLyme Disease

Condition Hierarchy (Ancestors)

GlossitisTongue DiseasesMouth DiseasesStomatognathic DiseasesGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsBorrelia InfectionsSpirochaetales InfectionsTick-Borne DiseasesVector Borne Diseases

Results Point of Contact

Title
Daša Stupica
Organization
University Medical center Ljubljana, Infectious Diseases Department
dasa.stupica@kclj.si
+386 1 522 21 10

Study Officials

  • Franc Strle, MD, PhD

    UMC Ljubljana

    STUDY DIRECTOR

  • Eva Ruzic-Sabljic, MD, PhD

    University of Ljubljana School of Medicine, Slovenia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

June 24, 2013

First Posted

May 23, 2014

Study Start

July 1, 2013

Primary Completion

December 1, 2014

Last Updated

June 30, 2015

Results First Posted

June 30, 2015

Record last verified: 2015-06

Locations

SL(1)