Erythema MigransNCT02145754
Culture Media for Borrelia Burgdorferi Sensu Lato
A study testing MKP media and BSK-H media in people with Erythema Migrans, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Erythema Migrans
- What is being tested?
- MKP media and BSK-H media
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 235 participants
- Where
- 1 siteSlovenia
- Study dates
- Jul 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- erythema migrans in patients > 18 years
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
UMC Ljubljana, Department of Infectious Diseases
Ljubljana, 1525
About this study
Official title: Comparison of Two Culture Media for Cultivation of Borrelia Burgdorferi Sensu Lato
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.
- Conditions
- Erythema Migrans
- Being tested
- MKP media, BSK-H media
- Keywords
- erythema migrans, Lyme borreliosis, Borrelia burgdorferi, skin culture, culture media
- Medical subject headings
- Glossitis, Benign Migratory, Lyme Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MKP mediaOther
one half of skin specimen was put in MKP media
BSK-H mediaOther
one half of skin specimen was put in BSK-H media
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: MKP media; Other: BSK-H media |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: weekly examination during 9 weeks of cultivating for individual specimen
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2014 (estimated)
- Study startJul 2013
- Primary completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Erythema MigransStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ljubljana School of Medicine, Slovenia
- Responsible party
- Principal investigator, Franc Strle, University Medical Centre Ljubljana
- Investigators
- Franc Strle, MD, PhD, Study director, UMC LjubljanaEva Ruzic-Sabljic, MD, PhD, Principal investigator, University of Ljubljana School of Medicine, Slovenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02145754
- Sponsor's protocol ID
- MKP,BSK-0613
- Status last verified
- Jun 2015
- First submitted
- 24 Jun 2013
- Last updated
- 30 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Culture Media for Cultivation of Borrelia Burgdorferi Sensu Lato
- ClinicalTrials.gov ID
- NCT02145754
- Acronym / sponsor ID
- MKP,BSK-0613
- Conditions
- Erythema Migrans
- Keywords
- erythema migrans, Lyme borreliosis, Borrelia burgdorferi, skin culture, culture media
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Collaborators
- University of Ljubljana School of Medicine, Slovenia
- Study start
- Jul 2013
- Primary completion
- Dec 2014 (actual)
- First posted
- 23 May 2014 (estimated)
- Results
- Posted 30 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MKP media versus BSK-H media | Active comparator | Other: MKP media, Other: BSK-H mediaone 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- erythema migrans in patients > 18 years
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MKP mediaone half of skin specimen was put in MKP media | Other | MKP media versus BSK-H media |
| BSK-H mediaone half of skin specimen was put in BSK-H media | Other | MKP media versus BSK-H media |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franc Strle, MD, PhD study director
UMC Ljubljana
Eva Ruzic-Sabljic, MD, PhD principal investigator
University of Ljubljana School of Medicine, Slovenia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MKP media and BSK-H media in people with Erythema Migrans, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2015.