Erythema Chronicum MigransNCT03337932
Duration of Doxycycline Treatment in MEM Patients
A study testing Doxycycline 100 milligram Oral Tablet bid, 7 days and Doxycycline 100 milligram Oral Tablet bid, 14 days in people with Erythema Chronicum Migrans, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
The purpose of this study is to compare the efficacy of 7-day versus 14-day doxycycline treatment in patients with multiple 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 Chronicum Migrans
- What is being tested?
- Doxycycline 100 milligram Oral Tablet bid, 7 days and Doxycycline 100 milligram Oral Tablet bid, 14 days
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 May 2018to 31 Dec 2027
- Phase
- Interventional
- 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
- multiple erythema migrans
Who cannot join
- pregnancy or lactation
- immunocompromised
- serious adverse event to doxycycline
- taking antibiotic with antiborrelial activity within 10 days
- extracutaneous manifestations of lyme borreliosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia1 site, 1 recruiting
- Recruiting
University Medical center Ljubljana
Ljubljana
Daša Stupica, MD, PhD, +386 31 689 324, dasa.stupica@kclj.si
Maša Velušček, MD, +386 1 522 21 10, masa.veluscek@kclj.si
About this study
Official title: Duration of Doxycycline Treatment in Patients With Multiple Erythema Migrans (MEM). A Randomized Clinical Trial
The purpose of this study is to compare the efficacy of 7-day versus 14-day doxycycline treatment in patients with multiple erythema migrans.
- Conditions
- Erythema Chronicum Migrans
- Being tested
- Doxycycline 100 milligram Oral Tablet bid, 7 days, Doxycycline 100 milligram Oral Tablet bid, 14 days, Controls without a history of lyme disease.
- Medical subject headings
- Erythema Chronicum Migrans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doxycycline 100 milligram Oral Tablet bid, 7 daysDrug
Patients will receive doxycycline for 7 days.
Doxycycline 100 milligram Oral Tablet bid, 14 daysDrug
Patients will receive doxycycline for 14 days.
Controls without a history of lyme disease.Drug
No intervention.
| Study group | Role | What they receive |
|---|---|---|
| MEM-7 days doxycycline | Active comparator | Not described Receives: Drug: Doxycycline 100 milligram Oral Tablet bid, 7 days |
| MEM-14 days doxycycline | Active comparator | Not described Receives: Drug: Doxycycline 100 milligram Oral Tablet bid, 14 days |
| Controls | Placebo comparator | Not described Receives: Drug: Controls without a history of lyme disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 14 days post-enrollment in patients treated for multiple erythema migrans with doxycycline for 7 or 14 days
At follow-up at 14 days patients will be examined physically and will be asked an open question about health-related symptoms. Symptoms that will newly develop or worsen since the onset of the multiple erythema migrans and which will have no other known medical explanation will be regarded as post-Lyme symptoms.
Complete response to treatment will be defined as a return to pre-Lyme health status. Partial response will be defined as the presence of post-Lyme symptoms, while occurrence of new objective signs of Lyme borreliosis will be interpreted as failure.
Measured: Study point: at 14 days post-enrollment.
Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 2 months post-enrollment in patients treated for multiple erythema migrans with doxycycline for 7 or 14 days
At follow-up at 2 months patients will be examined physically and will be asked an open question about health-related symptoms. Symptoms that will newly develop or worsen since the onset of the multiple erythema migrans and which will have no other known medical explanation will be regarded as post-Lyme symptoms.
Complete response to treatment will be defined as a return to pre-Lyme health status. Partial response will be defined as the presence of post-Lyme symptoms, while occurrence of new objective signs of Lyme borreliosis, and/or persistence of borreliae as detected by culture of skin re-biopsy sample, and/or persistence of erythema migrans at more than 2 months post-treatment will be interpreted as failure.
Measured: Study point: at 2 months post-enrollment.
Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 6 months post-enrollment in patients treated for multiple erythema migrans with doxycycline for 7 or 14 days
At follow-up at 6 months patients will be examined physically and will be asked an open question about health-related symptoms. Symptoms that will newly develop or worsen since the onset of the multiple erythema migrans and which will have no other known medical explanation will be regarded as post-Lyme symptoms.
Complete response to treatment will be defined as a return to pre-Lyme health status. Partial response will be defined as the presence of post-Lyme symptoms, while occurrence of new objective signs of Lyme borreliosis, and/or persistence of borreliae as detected by culture of skin re-biopsy sample, and/or persistence of erythema migrans at more than 2 months post-treatment will be interpreted as failure.
Measured: Study point: at 6 months post-enrollment.
Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 12 months post-enrollment in patients treated for multiple erythema migrans with doxycycline for 7 or 14 days
At 12 months patients will be examined physically and will be asked an open question about health-related symptoms. Symptoms that will newly develop or worsen since the onset of the multiple erythema migrans and which will have no other known medical explanation will be regarded as post-Lyme symptoms.
Complete response to treatment will be defined as a return to pre-Lyme health status. Partial response will be defined as the presence of post-Lyme symptoms, while occurrence of new objective signs of Lyme borreliosis, and/or persistence of borreliae as detected by culture of skin re-biopsy sample, and/or persistence of erythema migrans at more than 2 months post-treatment will be interpreted as failure.
Measured: Study point: at 12 months post-enrollment.
Secondary outcomes (1)
Change in occurrence of nonspecific symptoms from baseline to 6 months and to 12 months post-enrollment in patients with multiple erythema migrans and control subjects
Patients will complete a written questionnaire asking whether they had had any of 8 nonspecific symptoms (fatigue, arthralgias, headache, myalgias, paresthesias, memory difficulties, concentration difficulties, irritability) within the preceding week.
Control subjects will complete the same 8-symptom questionnaire as the patients within 14 days of the examination date of the corresponding patient at enrollment, and again at 6 and 12 months.
Patients and controls will grade the severity of each individual symptom on a 10-cm visual analogue scale (10 = most severe).
Measured: Study points will be: at enrollment, at 6, and at 12 months post-enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start1 May 2018
- 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 Chronicum 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
- 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
- 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
- NCT03337932
- Sponsor's protocol ID
- MEM-Doxy
- Status last verified
- Apr 2026
- First submitted
- 24 Oct 2017
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duration of Doxycycline Treatment in Patients With Multiple Erythema Migrans (MEM). A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03337932
- Acronym / sponsor ID
- MEM-Doxy
- Conditions
- Erythema Chronicum Migrans
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Nov 2017 (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 7-day versus 14-day doxycycline treatment in patients with multiple erythema migrans.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MEM-7 days doxycycline | Active comparator | Drug: Doxycycline 100 milligram Oral Tablet bid, 7 days |
| MEM-14 days doxycycline | Active comparator | Drug: Doxycycline 100 milligram Oral Tablet bid, 14 days |
| Controls | Placebo comparator | Drug: Controls without a history of lyme disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- multiple erythema migrans
Key exclusion criteria (5 listed)
- pregnancy or lactation
- immunocompromised
- serious adverse event to doxycycline
- taking antibiotic with antiborrelial activity within 10 days
- extracutaneous manifestations of lyme borreliosis
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 |
|---|---|---|
| Doxycycline 100 milligram Oral Tablet bid, 7 daysPatients will receive doxycycline for 7 days. | Drug | MEM-7 days doxycycline |
| Doxycycline 100 milligram Oral Tablet bid, 14 daysPatients will receive doxycycline for 14 days. | Drug | MEM-14 days doxycycline |
| Controls without a history of lyme disease.No intervention. | Drug | Controls |
Primary outcome
Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 14 days post-enrollment in patients treated for multiple erythema migrans with doxycycline for 7 or 14 days
Time frame: Study point: at 14 days post-enrollment.
At follow-up at 14 days patients will be examined physically and will be asked an open question about health-related symptoms. Symptoms that will newly develop or worsen since the onset of the multiple erythema migrans and which will have no other known medical explanation will be regarded as post-Lyme symptoms. Complete response to treatment will be defined as a return to pre-Lyme health status. Partial response will be defined as the presence of post-Lyme symptoms, while occurrence of new objective signs of Lyme borreliosis will be interpreted as failure.
Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 2 months post-enrollment in patients treated for multiple erythema migrans with doxycycline for 7 or 14 days
Time frame: Study point: at 2 months post-enrollment.
At follow-up at 2 months patients will be examined physically and will be asked an open question about health-related symptoms. Symptoms that will newly develop or worsen since the onset of the multiple erythema migrans and which will have no other known medical explanation will be regarded as post-Lyme symptoms. Complete response to treatment will be defined as a return to pre-Lyme health status. Partial response will be defined as the presence of post-Lyme symptoms, while occurrence of new objective signs of Lyme borreliosis, and/or persistence of borreliae as detected by culture of skin re-biopsy sample, and/or persistence of erythema migrans at more than 2 months post-treatment will be interpreted as failure.
Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 6 months post-enrollment in patients treated for multiple erythema migrans with doxycycline for 7 or 14 days
Time frame: Study point: at 6 months post-enrollment.
At follow-up at 6 months patients will be examined physically and will be asked an open question about health-related symptoms. Symptoms that will newly develop or worsen since the onset of the multiple erythema migrans and which will have no other known medical explanation will be regarded as post-Lyme symptoms. Complete response to treatment will be defined as a return to pre-Lyme health status. Partial response will be defined as the presence of post-Lyme symptoms, while occurrence of new objective signs of Lyme borreliosis, and/or persistence of borreliae as detected by culture of skin re-biopsy sample, and/or persistence of erythema migrans at more than 2 months post-treatment will be interpreted as failure.
Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 12 months post-enrollment in patients treated for multiple erythema migrans with doxycycline for 7 or 14 days
Time frame: Study point: at 12 months post-enrollment.
At 12 months patients will be examined physically and will be asked an open question about health-related symptoms. Symptoms that will newly develop or worsen since the onset of the multiple erythema migrans and which will have no other known medical explanation will be regarded as post-Lyme symptoms. Complete response to treatment will be defined as a return to pre-Lyme health status. Partial response will be defined as the presence of post-Lyme symptoms, while occurrence of new objective signs of Lyme borreliosis, and/or persistence of borreliae as detected by culture of skin re-biopsy sample, and/or persistence of erythema migrans at more than 2 months post-treatment will be interpreted as failure.
1 secondary outcome
Change in occurrence of nonspecific symptoms from baseline to 6 months and to 12 months post-enrollment in patients with multiple erythema migrans and control subjects
Time frame: Study points will be: at enrollment, at 6, and at 12 months post-enrollment.
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 29 Apr 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
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?
A study testing Doxycycline 100 milligram Oral Tablet bid, 7 days and Doxycycline 100 milligram Oral Tablet bid, 14 days in people with Erythema Chronicum 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 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 29 Apr 2026. 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. Some participants in this study may receive a placebo. 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?
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 (+386 31 689 324, dasa.stupica@kclj.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 14 days post-enrollment in patients treated for multiple erythema migrans with doxycycline for 7 or 14 days (time frame: Study point: at 14 days post-enrollment.). The study lists 4 primary outcomes in all. 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 29 Apr 2026.