Multiple Erythema MigransNCT01163994
Antibiotic Treatment of Multiple Erythema Migrans
A study testing ceftriaxone, doxycycline and erythema migrans patients treated with doxycycline in people with Multiple Erythema Migrans, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
The purpose of this study is to compare the efficacy and safety of 15-day ceftriaxone versus 15-day doxycycline treatment in patients with multiple erythema migrans. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Erythema Migrans
- What is being tested?
- ceftriaxone, doxycycline and erythema migrans patients treated with doxycycline
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteSlovenia
- Study dates
- Jun 2010to Oct 2017
- 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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- multiple erythema migrans in patients > 15 years
Who cannot join
- a history of Lyme borreliosis in the past
- pregnancy or lactation
- immunocompromised status
- serious adverse event to doxycycline or beta lactam antibiotic
- 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, +386 1 522 2110, cerar.dasa@gmail.com
Franc Strle, MD, +386 1 5222610, franc.strle@kclj.si
About this study
Official title: Comparison of Ceftriaxone and Doxycycline for Treatment of Multiple Erythema Migrans
The purpose of this study is to compare the efficacy and safety of 15-day ceftriaxone versus 15-day doxycycline treatment in patients with multiple erythema migrans.
- Conditions
- Multiple Erythema Migrans
- Being tested
- ceftriaxone, doxycycline, erythema migrans patients treated with doxycycline
- Keywords
- erythema migrans, Lyme borreliosis, ceftriaxone treatment, doxycycline treatment, outcome, subjective symptoms
- 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.
ceftriaxoneDrug
intravenously, 2 g, qd, 15 days
doxycyclineDrug
orally, 100 mg, bid, 15 days
erythema migrans patients treated with doxycyclineOther
orally, 100 mg, bid, 15 days
| Study group | Role | What they receive |
|---|---|---|
| MEM-ceftriaxone | Active comparator | Not described Receives: Drug: ceftriaxone |
| MEM-doxycycline | Active comparator | Not described Receives: Drug: doxycycline |
| controls | No intervention | Not described |
| EM-doxycycline | Active comparator | Not described Receives: Other: erythema migrans patients treated with doxycycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days.
Measured: enrolling 3 years, 1 year follow-up for individual participant: first assessment at baseline
Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days.
Measured: second assessment at 14 days postenrollment
Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days.
Measured: third assessment at 2 months postenrollment
Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days.
Measured: fourth assessment at 6 months postenrollment
Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days.
Measured: fifth assessment at 12 months postenrollment
Secondary outcomes (8)
Comparison of subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, or irritability between patients treated with antibiotic for multiple erythema migrans and control subjects without a history of Lyme borreliosis.
Measured: enrolling 3 years, 1 year follow-up for individual participant: first assessment at baseline
Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients with solitary versus multiple erythema migrans after antibiotic treatment.
Measured: enrolling 3 years, 1 year follow-up for individual participant: at baseline and at 14 days, 2, 6, and 12 months thereafter
Comparison of subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, or irritability between patients treated with antibiotic for multiple erythema migrans and control subjects without a history of Lyme borreliosis.
Measured: second assessment at 6 months postenrollment
Comparison of subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, or irritability between patients treated with antibiotic for multiple erythema migrans and control subjects without a history of Lyme borreliosis.
Measured: third assessment at 6 months postenrollment
Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients with solitary versus multiple erythema migrans after antibiotic treatment.
Measured: second assessment at 14 days postenrollment
Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients with solitary versus multiple erythema migrans after antibiotic treatment.
Measured: third assessment at 2 months postenrollment
Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients with solitary versus multiple erythema migrans after antibiotic treatment.
Measured: fourth assessment at 6 months postenrollment
Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients with solitary versus multiple erythema migrans after antibiotic treatment.
Measured: fifth assessment at 12 months postenrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionOct 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Franc Strle, University Medical Centre Ljubljana
- Investigators
- Franc Strle, MD, Study chair, UMC LjubljanaDasa Stupica, MD, Principal investigator, UMC Ljubljana, Department of Infectious Diseases Ljubljana, Slovenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01163994
- Sponsor's protocol ID
- MEM-0510
- Status last verified
- May 2017
- First submitted
- 13 Jul 2010
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Veluscek M, Bajrovic FF, Strle F, Stupica D. Doxycycline-induced photosensitivity in patients treated for erythema migrans. BMC Infect Dis. 2018 Aug 3;18(1):365. doi: 10.1186/s12879-018-3270-y.
PubMed 30075748Stupica D, Veluscek M, Blagus R, Bogovic P, Rojko T, Cerar T, Strle F. Oral doxycycline versus intravenous ceftriaxone for treatment of multiple erythema migrans: an open-label alternate-treatment observational trial. J Antimicrob Chemother. 2018 May 1;73(5):1352-1358. doi: 10.1093/jac/dkx534.
PubMed 29385444
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ceftriaxone and Doxycycline for Treatment of Multiple Erythema Migrans
- ClinicalTrials.gov ID
- NCT01163994
- Acronym / sponsor ID
- MEM-0510
- Conditions
- Multiple Erythema Migrans
- Keywords
- erythema migrans, Lyme borreliosis, ceftriaxone treatment, doxycycline treatment, outcome, subjective symptoms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 16 Jul 2010 (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 purpose of this study is to compare the efficacy and safety of 15-day ceftriaxone versus 15-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
- 4
| Arm | Type | Receives |
|---|---|---|
| MEM-ceftriaxone | Active comparator | Drug: ceftriaxone |
| MEM-doxycycline | Active comparator | Drug: doxycycline |
| controls | No intervention | – |
| EM-doxycycline | Active comparator | Other: erythema migrans patients treated with doxycycline |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- multiple erythema migrans in patients > 15 years
Key exclusion criteria (5 listed)
- a history of Lyme borreliosis in the past
- pregnancy or lactation
- immunocompromised status
- serious adverse event to doxycycline or beta lactam antibiotic
- 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 |
|---|---|---|
| ceftriaxoneintravenously, 2 g, qd, 15 days | Drug | MEM-ceftriaxone |
| doxycyclineorally, 100 mg, bid, 15 days | Drug | MEM-doxycycline |
| erythema migrans patients treated with doxycyclineorally, 100 mg, bid, 15 days | Other | EM-doxycycline |
Primary outcome
Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days.
Time frame: enrolling 3 years, 1 year follow-up for individual participant: first assessment at baseline
Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days.
Time frame: second assessment at 14 days postenrollment
Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days.
Time frame: third assessment at 2 months postenrollment
Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days.
Time frame: fourth assessment at 6 months postenrollment
Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days.
Time frame: fifth assessment at 12 months postenrollment
8 secondary outcomes
Comparison of subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, or irritability between patients treated with antibiotic for multiple erythema migrans and control subjects without a history of Lyme borreliosis.
Time frame: enrolling 3 years, 1 year follow-up for individual participant: first assessment at baseline
Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients with solitary versus multiple erythema migrans after antibiotic treatment.
Time frame: enrolling 3 years, 1 year follow-up for individual participant: at baseline and at 14 days, 2, 6, and 12 months thereafter
Comparison of subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, or irritability between patients treated with antibiotic for multiple erythema migrans and control subjects without a history of Lyme borreliosis.
Time frame: second assessment at 6 months postenrollment
Comparison of subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, or irritability between patients treated with antibiotic for multiple erythema migrans and control subjects without a history of Lyme borreliosis.
Time frame: third assessment at 6 months postenrollment
Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients with solitary versus multiple erythema migrans after antibiotic treatment.
Time frame: second assessment at 14 days postenrollment
Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients with solitary versus multiple erythema migrans after antibiotic treatment.
Time frame: third assessment at 2 months postenrollment
Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients with solitary versus multiple erythema migrans after antibiotic treatment.
Time frame: fourth assessment at 6 months postenrollment
Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients with solitary versus multiple erythema migrans after antibiotic treatment.
Time frame: fifth assessment at 12 months postenrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
- Derived from this study: PubMed 30075748Veluscek M, Bajrovic FF, Strle F, Stupica D. Doxycycline-induced photosensitivity in patients treated for erythema migrans. BMC Infect Dis. 2018 Aug 3;18(1):365. doi: 10.1186/s12879-018-3270-y.
- Derived from this study: PubMed 29385444Stupica D, Veluscek M, Blagus R, Bogovic P, Rojko T, Cerar T, Strle F. Oral doxycycline versus intravenous ceftriaxone for treatment of multiple erythema migrans: an open-label alternate-treatment observational trial. J Antimicrob Chemother. 2018 May 1;73(5):1352-1358. doi: 10.1093/jac/dkx534.
Related trials for Multiple Erythema Migrans
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Duration of Doxycycline Treatment in MEM Patients
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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 study chair
UMC Ljubljana
Dasa Stupica, MD principal investigator
UMC Ljubljana, Department of Infectious Diseases Ljubljana, 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 ceftriaxone, doxycycline and erythema migrans patients treated with doxycycline in people with Multiple 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 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: status not confirmed, as of the sponsor's last update on 5 May 2017. 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 (+386 1 522 2110, cerar.dasa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days. (time frame: enrolling 3 years, 1 year follow-up for individual participant: first assessment at baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01163994, which also lists 2 linked publications.
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 5 May 2017.