Erythema MigransPhase 3NCT03966014
Different Amoxicillin Treatment Regimens in Erythema Migrans Patients
A Phase 3 study testing EM-amoxicillin 3 x 10 days and EM-amoxicillin 3 x 14 days in people with Erythema Migrans, run by University Medical Centre Ljubljana at 2 sites in Slovenia.
Trial summary
The purpose of this study is to compare the efficacy of different amoxicilline treatment regimens in patients with erythema migrans. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Erythema Migrans
- What is being tested?
- EM-amoxicillin 3 x 10 days and EM-amoxicillin 3 x 14 days
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesSlovenia
- Study dates
- 1 Jun 2019to 31 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- erythema migrans
Who cannot join
- pregnancy
- extracutaneous manifestations of Lyme borreliosis
- immunocompromising state
- serious adverse event to beta lactam antibiotic
- receiving antibiotic with antiborrelial activity within 10 days
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia2 sites, 2 recruiting
- Recruiting
University Medical Centre Ljubljana
Ljubljana
Daša Stupica, MD, PhD, +386 31 689 324, dasa.stupica@kclj.si
Maša Velušček, MD, +386 31 332 904, masa.veluscek@kclj.si
- Not yet recruiting
University Medical Centre Ljubljana
Ljubljana
Daša Stupica, MD, PhD, +386 31 689 324, dasa.stupica@kclj.si
Maša Velušček, MD, +386 31 332 904, masa.veluscek@kclj.si
About this study
Official title: Different Duration and Dosing of Amoxicillin in Patients With Erythema Migrans. A Randomized Clinical Trial.
The purpose of this study is to compare the efficacy of different amoxicilline treatment regimens in patients with erythema migrans.
- Conditions
- Erythema Migrans
- Being tested
- EM-amoxicillin 3 x 10 days, EM-amoxicillin 3 x 14 days, Controls
- 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.
EM-amoxicillin 3 x 10 daysDrug
Also called 10 days
Patients will receive amoxicillin 500 milligram tid for 10 days
EM-amoxicillin 3 x 14 daysDrug
Also called 14 days
Patients will receive amoxicillin 500 milligram tid for 14 days
ControlsOther
No intervention.
| Study group | Role | What they receive |
|---|---|---|
| EM-amoxicillin 3 x 10 days | Active comparator | amoxicillin for 10 days Receives: Drug: EM-amoxicillin 3 x 10 days |
| EM-amoxicillin 3 x 14 days | Active comparator | amoxicillin for 14 days Receives: Drug: EM-amoxicillin 3 x 14 days |
| Controls | Other | controls without Lyme borreliosis Receives: Other: Controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number (frequency) of patients with objective manifestations of Lyme borreliosis or subjective Lyme borreliosis-associated/post-Lyme borreliosis symptoms
At each visit physical examination wil be performed and clinical signs indicating objective manifestations of Lyme borreliosis, such as erythema migrans, will be searched for and documented. At each visit patients will be asked an open question about any health-related symptoms that had newly developed or worsened since the onset of erythema migrans. If these symptoms will have no other known medical explanation, they will be regarded as Lyme borreliosis-associated constitutional symptoms at enrolment or post-Lyme borreliosis symptoms at follow-up.
Measured: One year follow-up
Secondary outcomes (1)
Number (frequency) of patients with nonspecific symptoms
At each visit patients will be asked to complete a written questionnaire asking whether they had had any of eight non-specific symptoms (fatigue, arthralgias, headache,myalgias, paraesthesias, memory difficulties, concentration difficulties and irritability) within the preceding week.
Measured: One year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start1 Jun 2019
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 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
- Responsible party
- Principal investigator, Daša Stupica, University Medical Centre Ljubljana
- Investigators
- Daša Stupica, MD PhD, Principal investigator, Department of Infectious Diseases, University Medical Centre Ljubljana, Slovenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03966014
- Sponsor's protocol ID
- Amoxy 10-14
- Status last verified
- Mar 2026
- First submitted
- 24 May 2019
- Last updated
- 25 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Duration and Dosing of Amoxicillin in Patients With Erythema Migrans. A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT03966014
- Acronym / sponsor ID
- Amoxy 10-14
- Conditions
- Erythema Migrans
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Collaborators
- University of Ljubljana School of Medicine, Slovenia
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 May 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 purpose of this study is to compare the efficacy of different amoxicilline treatment regimens in patients with erythema migrans.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EM-amoxicillin 3 x 10 days | Active comparator | Drug: EM-amoxicillin 3 x 10 daysamoxicillin for 10 days |
| EM-amoxicillin 3 x 14 days | Active comparator | Drug: EM-amoxicillin 3 x 14 daysamoxicillin for 14 days |
| Controls | Other | Other: Controlscontrols without Lyme borreliosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- erythema migrans
Key exclusion criteria (5 listed)
- pregnancy
- extracutaneous manifestations of Lyme borreliosis
- immunocompromising state
- serious adverse event to beta lactam antibiotic
- receiving 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 |
|---|---|---|
| EM-amoxicillin 3 x 10 daysAlso: 10 daysPatients will receive amoxicillin 500 milligram tid for 10 days | Drug | EM-amoxicillin 3 x 10 days |
| EM-amoxicillin 3 x 14 daysAlso: 14 daysPatients will receive amoxicillin 500 milligram tid for 14 days | Drug | EM-amoxicillin 3 x 14 days |
| ControlsNo intervention. | Other | Controls |
Primary outcome
Number (frequency) of patients with objective manifestations of Lyme borreliosis or subjective Lyme borreliosis-associated/post-Lyme borreliosis symptoms
Time frame: One year follow-up
At each visit physical examination wil be performed and clinical signs indicating objective manifestations of Lyme borreliosis, such as erythema migrans, will be searched for and documented. At each visit patients will be asked an open question about any health-related symptoms that had newly developed or worsened since the onset of erythema migrans. If these symptoms will have no other known medical explanation, they will be regarded as Lyme borreliosis-associated constitutional symptoms at enrolment or post-Lyme borreliosis symptoms at follow-up.
1 secondary outcome
Number (frequency) of patients with nonspecific symptoms
Time frame: One year follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
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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.
Daša Stupica, MD PhD principal investigator
Department of Infectious Diseases, University Medical Centre Ljubljana, Slovenia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing EM-amoxicillin 3 x 10 days and EM-amoxicillin 3 x 14 days in people with Erythema Migrans, run by University Medical Centre Ljubljana at 2 sites 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 5 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: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daša Stupica, MD PhD (+38631689324, dasa.stupica@kclj.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number (frequency) of patients with objective manifestations of Lyme borreliosis or subjective Lyme borreliosis-associated/post-Lyme borreliosis symptoms (time frame: One year 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 25 Mar 2026.