Erythema MigransNCT02147249
Cytokines and Chemokines in Erythema Migrans
A study testing antibiotic treatment in people with Erythema Migrans, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
The main objective of this study is to characterize the inflammatory proteins, gene polymorphisms, and transcriptome profiles in patients with erythema migrans to gain better insight into pathogenesis of early Lyme borreliosis and to define new immune modulators that could serve as biomarkers of disease activity. 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?
- antibiotic treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSlovenia
- Study dates
- Jul 2013to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Trial locations and contacts
1 site in 1 country.
Slovenia1 site, 1 recruiting
- Recruiting
UMC Ljubljana, Department of Infectious Diseases
Ljubljana, 1525
Dasa Stupica, MD,PhD, +386 1 5222110, cerar.dasa@gmail.com
Franc Strle, MD,PhD, +386 1 522 2610, franc.strle@kclj.si
About this study
Official title: Inflammatory Proteins, Gene Polymorphisms, and Transcriptome Profiles in Patients With Erythema Migrans
The main objective of this study is to characterize the inflammatory proteins, gene polymorphisms, and transcriptome profiles in patients with erythema migrans to gain better insight into pathogenesis of early Lyme borreliosis and to define new immune modulators that could serve as biomarkers of disease activity.
- Conditions
- Erythema Migrans
- Being tested
- antibiotic treatment
- Keywords
- erythema migrans, Lyme borreliosis, inflammation, outcome
- Medical subject headings
- Glossitis, Benign Migratory, Lyme Disease, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antibiotic treatmentDrug
Patient will be treated with: doxycycline orally, 100 mg, bid, 14 days or cefuroxime axetil orally, 500 mg, bid, 14 days or amoxicillin orally, 500 mg, tid, 14 days
| Study group | Role | What they receive |
|---|---|---|
| erythema migrans patients treated with antibiotics | Experimental | adult patients with erythema migrans will be treated with oral antibiotics Receives: Drug: antibiotic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
inflammatory proteins in erythema migrans patients
The inflammatory immune profiles will be assessed using Luminex to measure the expression of cytokines and chemokines representative of innate and adaptive TH1, TH2, TH17, and B cell responses in serum and if available, skin, of patients during active infection and after treatment.
Measured: up to 12 months follow-up
Secondary outcomes (1)
gene polymorphisms in erythema migrans patients
The expression of disease-relevant genomic variants will be assessed using ImmunoChip.
Measured: at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2014 (estimated)
- Study startJul 2013
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ljubljana School of Medicine, Slovenia, Medical University of Vienna, Harvard University
- Responsible party
- Principal investigator, Franc Strle, University Medical Centre Ljubljana
- Investigators
- Franc Strle, MD, PhD, Study chair, UMC LjubljanaDasa Stupica, MD, PhD, Principal investigator, UMC Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02147249
- Sponsor's protocol ID
- EM-0613
- Status last verified
- Apr 2019
- First submitted
- 24 Jun 2013
- Last updated
- 22 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Proteins, Gene Polymorphisms, and Transcriptome Profiles in Patients With Erythema Migrans
- ClinicalTrials.gov ID
- NCT02147249
- Acronym / sponsor ID
- EM-0613
- Conditions
- Erythema Migrans
- Keywords
- erythema migrans, Lyme borreliosis, inflammation, outcome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Collaborators
- University of Ljubljana School of Medicine, Slovenia, Medical University of Vienna, Harvard University
- Study start
- Jul 2013
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 26 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this study is to characterize the inflammatory proteins, gene polymorphisms, and transcriptome profiles in patients with erythema migrans to gain better insight into pathogenesis of early Lyme borreliosis and to define new immune modulators that could serve as biomarkers of disease activity.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| erythema migrans patients treated with antibiotics | Experimental | Drug: antibiotic treatmentadult patients with erythema migrans will be treated with oral antibiotics |
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 (2 listed)
- pregnancy or lactation
- taking antibiotic with antiborrelial activity within 10 days
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 |
|---|---|---|
| antibiotic treatmentPatient will be treated with: doxycycline orally, 100 mg, bid, 14 days or cefuroxime axetil orally, 500 mg, bid, 14 days or amoxicillin orally, 500 mg, tid, 14 days | Drug | erythema migrans patients treated with antibiotics |
Primary outcome
inflammatory proteins in erythema migrans patients
Time frame: up to 12 months follow-up
The inflammatory immune profiles will be assessed using Luminex to measure the expression of cytokines and chemokines representative of innate and adaptive TH1, TH2, TH17, and B cell responses in serum and if available, skin, of patients during active infection and after treatment.
1 secondary outcome
gene polymorphisms in erythema migrans patients
Time frame: at enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2019.
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Erythema Migrans of Lyme Disease
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Anti-phospolipid Antibodies in Lyme Borreliosis
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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 chair
UMC Ljubljana
Dasa Stupica, MD, PhD principal investigator
UMC Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing antibiotic treatment 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 2 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: status not confirmed, as of the sponsor's last update on 22 Apr 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dasa Stupica, MD,PhD (+386 1 5222110, cerar.dasa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
inflammatory proteins in erythema migrans patients (time frame: up to 12 months follow-up). 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 22 Apr 2019.