Erythema Chronicum MigransNCT03153267
Duration of Doxycycline Treatment in EM Patients
A study testing Doxycycline 100 MG Oral Tablet bid, 7 days and Doxycycline 100 MG 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 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 MG Oral Tablet bid, 7 days and Doxycycline 100 MG 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
- 300 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Jun 2017to 31 Dec 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- solitary erythema migrans
Who cannot join
- pregnancy or lactation
- immunocompromised
- serious adverse event to doxycycline
- taking antibiotic with antiborrelial activity within 10 days
- multiple erythema migrans or extracutaneous manifestations of lyme borreliosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Duration of Doxycycline Treatment in Patients With Erythema Migrans (EM). 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 erythema migrans.
- Conditions
- Erythema Chronicum Migrans
- Being tested
- Doxycycline 100 MG Oral Tablet bid, 7 days, Doxycycline 100 MG 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 MG Oral Tablet bid, 7 daysDrug
Patients will receive doxycycline for 7 days.
Doxycycline 100 MG 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 |
|---|---|---|
| EM-7 days doxycycline | Active comparator | Not described Receives: Drug: Doxycycline 100 MG Oral Tablet bid, 7 days |
| EM-14 days doxycycline | Active comparator | Not described Receives: Drug: Doxycycline 100 MG 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.
Treatment outcome in patients treated for erythema migrans with doxycycline for 7 or 14 days
Objective sequelae and post-treatment subjective new or increased symptoms (NOIS) in patients treated for erythema migrans with doxycycline for 7 or 14 days.
Measured: At 12 months after enrollment.
Secondary outcomes (1)
Comparison of nonspecific symptoms in patients with erythema migrans and control subjects
Number of patients after treatment with doxycycline for 7 or 14 days for erythema migrans and number of control subjects (without a history o Lyme borreliosis) with nonspecific symptoms.
Measured: At 12 months after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start1 Jun 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 300 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 Mecical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03153267
- Sponsor's protocol ID
- EM-Doxy714
- Status last verified
- Apr 2019
- First submitted
- 16 Mar 2017
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stupica D, Collinet-Adler S, Blagus R, Gomiscek A, Cerar Kisek T, Ruzic-Sabljic E, Veluscek M. Treatment of erythema migrans with doxycycline for 7 days versus 14 days in Slovenia: a randomised open-label non-inferiority trial. Lancet Infect Dis. 2023 Mar;23(3):371-379. doi: 10.1016/S1473-3099(22)00528-X. Epub 2022 Oct 6.
PubMed 36209759
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duration of Doxycycline Treatment in Patients With Erythema Migrans (EM). A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT03153267
- Acronym / sponsor ID
- EM-Doxy714
- Conditions
- Erythema Chronicum Migrans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Collaborators
- University of Ljubljana School of Medicine, Slovenia
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 15 May 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 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-7 days doxycycline | Active comparator | Drug: Doxycycline 100 MG Oral Tablet bid, 7 days |
| EM-14 days doxycycline | Active comparator | Drug: Doxycycline 100 MG 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)
- solitary erythema migrans
Key exclusion criteria (5 listed)
- pregnancy or lactation
- immunocompromised
- serious adverse event to doxycycline
- taking antibiotic with antiborrelial activity within 10 days
- multiple erythema migrans or 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 MG Oral Tablet bid, 7 daysPatients will receive doxycycline for 7 days. | Drug | EM-7 days doxycycline |
| Doxycycline 100 MG Oral Tablet bid, 14 daysPatients will receive doxycycline for 14 days. | Drug | EM-14 days doxycycline |
| Controls without a history of lyme disease.No intervention. | Drug | Controls |
Primary outcome
Treatment outcome in patients treated for erythema migrans with doxycycline for 7 or 14 days
Time frame: At 12 months after enrollment.
Objective sequelae and post-treatment subjective new or increased symptoms (NOIS) in patients treated for erythema migrans with doxycycline for 7 or 14 days.
1 secondary outcome
Comparison of nonspecific symptoms in patients with erythema migrans and control subjects
Time frame: At 12 months after enrollment.
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 25 Mar 2020.
- Derived from this study: PubMed 36209759Stupica D, Collinet-Adler S, Blagus R, Gomiscek A, Cerar Kisek T, Ruzic-Sabljic E, Veluscek M. Treatment of erythema migrans with doxycycline for 7 days versus 14 days in Slovenia: a randomised open-label non-inferiority trial. Lancet Infect Dis. 2023 Mar;23(3):371-379. doi: 10.1016/S1473-3099(22)00528-X. Epub 2022 Oct 6.
- Individual participant dataSharing planned: No
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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.
Daša Stupica, MD PhD principal investigator
University Mecical 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 MG Oral Tablet bid, 7 days and Doxycycline 100 MG 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: finished, as of the sponsor's last update on 25 Mar 2020. 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?
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?
Treatment outcome in patients treated for erythema migrans with doxycycline for 7 or 14 days (time frame: At 12 months after enrollment.). 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 NCT03153267, which also lists 1 linked publication.
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 2020.