Erythema MigransNCT03980015
Inflammatory Responses in Solitary and Multiple Erythema Migrans
An observational study of Erythema Migrans, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
The investigators will evaluate differences in host immune responses (levels of cytokines and chemokines, representative of innate, Th1, and Th17 immune responses) in acute sera from adult patients with solitary or multiple 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?
- antibiotic treatment
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 134 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Jun 2006to 31 May 2019
- Phase
- Observational
- 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
Study population: Adult patients with erythema migrans
Who may be able to join
- erythema migrans in patients > 18 years
- Borrelia afzelii isolated from skin
Who cannot join
- pregnancy or immunocompromising conditions
- taking antibiotic with antiborrelial activity within 10 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Inflammatory Responses in Borrelia Afzelii Culture Positive Patients With Early Disseminated or Early Localized Lyme Borreliosis
The investigators will evaluate differences in host immune responses (levels of cytokines and chemokines, representative of innate, Th1, and Th17 immune responses) in acute sera from adult patients with solitary or multiple erythema migrans.
- Conditions
- Erythema Migrans
- Being tested
- antibiotic treatment
- Medical subject headings
- Glossitis, Benign Migratory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antibiotic treatmentOther
Patients were treated with: ceftriaxone intravenously 2 g OD for 14 days or doxycycline orally 100 mg bid for 10 to 14 days or cefuroxime axetil orally 500 mg bid for 14 days or amoxicillin orally 500 mg tid for 14 days
| Study group | Role | What they receive |
|---|---|---|
| erythema migrans | patients with erythema migrans Receives: Other: 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 of patients at enrollment (during active infection).
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 posted10 Jun 2019
- Study start1 Jun 2006
- Primary completion31 Dec 2016
- Study completion31 May 2019
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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 134 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, Daša Stupica, University Medical Centre Ljubljana
- Investigators
- Daša Stupica, MD PhD, Principal investigator, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03980015
- Sponsor's protocol ID
- MEM vs EM cyto
- Status last verified
- Jun 2019
- First submitted
- 5 Jun 2019
- Last updated
- 11 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Responses in Borrelia Afzelii Culture Positive Patients With Early Disseminated or Early Localized Lyme Borreliosis
- ClinicalTrials.gov ID
- NCT03980015
- Acronym / sponsor ID
- MEM vs EM cyto
- Conditions
- Erythema Migrans
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Collaborators
- University of Ljubljana School of Medicine, Slovenia
- Study start
- 1 Jun 2006 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 10 Jun 2019 (actual)
- 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 investigators will evaluate differences in host immune responses (levels of cytokines and chemokines, representative of innate, Th1, and Th17 immune responses) in acute sera from adult patients with solitary or multiple erythema migrans.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| erythema migrans | – | Other: antibiotic treatmentpatients with erythema migrans |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with erythema migrans
Key inclusion criteria (2 listed)
- erythema migrans in patients > 18 years
- Borrelia afzelii isolated from skin
Key exclusion criteria (2 listed)
- pregnancy or immunocompromising conditions
- 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 treatmentPatients were treated with: ceftriaxone intravenously 2 g OD for 14 days or doxycycline orally 100 mg bid for 10 to 14 days or cefuroxime axetil orally 500 mg bid for 14 days or amoxicillin orally 500 mg tid for 14 days | Other | erythema migrans |
Primary outcome
inflammatory proteins in erythema migrans patients
Time frame: at enrollment
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 of patients at enrollment (during active infection).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2019.
- Individual participant dataSharing planned: Undecided
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Erythema Migrans of Lyme Disease
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Anti-phospolipid Antibodies in Lyme Borreliosis
Patients With Different Manifestations of Lyme Borreliosis, Persons With Nonspecific Symptoms and Positive Borrelia Antibodies in Serum
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.
Daša Stupica, MD PhD principal investigator
University Medical Centre Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 2 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: finished, as of the sponsor's last update on 11 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
inflammatory proteins in erythema migrans patients (time frame: at enrollment). 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 11 Jun 2019.