Lyme BorreliosisNCT01475708
Doxycycline in Therapy of Erythema Migrans
An observational study of Lyme Borreliosis, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
The investigators will compare the outcome of three groups of erythema migrans patients treated with doxycycline: a group without any accompanying symptoms, with mild symptoms and with severe symptoms that require lumbar puncture. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lyme Borreliosis
- What is being tested?
- Doxycycline
- How many people
- 400 participants
- Where
- 1 siteSlovenia
- Study dates
- May 2011to Nov 2014
- 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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with erythema migrans reffered to Lyme Borreliosis outpatient clinic of the University Medical Center Ljubljana, Slovenia, Department of Infectious Diseases.
Who may be able to join
- presence of erythema migrans
- >15 years old
- informed consent
Who cannot join
- pregnancy
- lactation
- multiple erythema migrans
- already treated with antibiotic for this episode of Lyme borreliosis
- allergy to doxycycline
- treatment with drugs with known interactions with doxycycline
- cerebrospinal fluid pleocytosis
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
UMC Ljubljana, Department of Infectious Diseases
Ljubljana, 1000
About this study
Official title: Doxycycline in Therapy of Erythema Migrans - do the Accompanying Symptoms Influence the Outcome?
The investigators will compare the outcome of three groups of erythema migrans patients treated with doxycycline: a group without any accompanying symptoms, with mild symptoms and with severe symptoms that require lumbar puncture.
Read the detailed description
Patients with erythema migrans treated with doxycycline for two weeks will be followed-up for one year (at 2 weeks, 2, 6 and 12 months) clinically and also by filling in the questionnaire to assess the presence of certain symptoms. Also the control group of their friends or relatives without a history of Lyme borreliosis will be included. The presence of their (unspecific) symptoms will also be recorded by the questionnaire at the time of enrollment and at 6 and 12 months.
- Conditions
- Lyme Borreliosis
- Being tested
- Doxycycline
- Keywords
- Lyme borreliosis, Erythema migrans, Doxycycline, Subjective symptoms, Outcome
- Medical subject headings
- Lyme Disease, Glossitis, Benign Migratory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxycyclineDrug
Also called Doxy
100 mg PO bid, 14 days
| Study group | Role | What they receive |
|---|---|---|
| no symptoms | patients with erythema migrans and no additional newly onset symptoms treated with doxycycline Receives: Drug: Doxycycline | |
| mild symptoms | patients with erythema migrans and mild unspecific newly onset symptoms treated with doxycycline Receives: Drug: Doxycycline | |
| severe symptoms-lumbar puncture | patients with erythema migrans and newly onset intense "neurologic" symptoms with lumbar puncture performed, treated with doxycycline Receives: Drug: Doxycycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing of objective sequelae and post-treatment subjective symptoms in three groups of erythema migrans patients treated with doxycycline: with no accompanying symptoms, with mild and with severe symptoms at the beginning.
Measured: 1 year follow-up
Secondary outcomes (1)
Comparison of subjective symptoms between erythema migrans patients treated with doxycycline and control subjects without a history of Lyme borreliosis.
Measured: 1 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 posted21 Nov 2011 (estimated)
- Study startMay 2011
- Primary completionOct 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lyme BorreliosisStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
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 PhD, Study chair, UMC Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01475708
- Sponsor's protocol ID
- EM-DOXY
- Status last verified
- Mar 2016
- First submitted
- 16 Nov 2011
- Last updated
- 24 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Doxycycline in Therapy of Erythema Migrans - do the Accompanying Symptoms Influence the Outcome?
- ClinicalTrials.gov ID
- NCT01475708
- Acronym / sponsor ID
- EM-DOXY
- Conditions
- Lyme Borreliosis
- Keywords
- Lyme borreliosis, Erythema migrans, Doxycycline, Subjective symptoms, Outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 21 Nov 2011 (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 investigators will compare the outcome of three groups of erythema migrans patients treated with doxycycline: a group without any accompanying symptoms, with mild symptoms and with severe symptoms that require lumbar puncture.
Detailed description
Patients with erythema migrans treated with doxycycline for two weeks will be followed-up for one year (at 2 weeks, 2, 6 and 12 months) clinically and also by filling in the questionnaire to assess the presence of certain symptoms. Also the control group of their friends or relatives without a history of Lyme borreliosis will be included. The presence of their (unspecific) symptoms will also be recorded by the questionnaire at the time of enrollment and at 6 and 12 months.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| no symptoms | – | Drug: Doxycyclinepatients with erythema migrans and no additional newly onset symptoms treated with doxycycline |
| mild symptoms | – | Drug: Doxycyclinepatients with erythema migrans and mild unspecific newly onset symptoms treated with doxycycline |
| severe symptoms-lumbar puncture | – | Drug: Doxycyclinepatients with erythema migrans and newly onset intense "neurologic" symptoms with lumbar puncture performed, treated with doxycycline |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with erythema migrans reffered to Lyme Borreliosis outpatient clinic of the University Medical Center Ljubljana, Slovenia, Department of Infectious Diseases.
Key inclusion criteria (3 listed)
- presence of erythema migrans
- >15 years old
- informed consent
Key exclusion criteria (7 listed)
- pregnancy
- lactation
- multiple erythema migrans
- already treated with antibiotic for this episode of Lyme borreliosis
- allergy to doxycycline
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 |
|---|---|---|
| DoxycyclineAlso: Doxy100 mg PO bid, 14 days | Drug | mild symptoms, no symptoms, severe symptoms-lumbar puncture |
Primary outcome
Comparing of objective sequelae and post-treatment subjective symptoms in three groups of erythema migrans patients treated with doxycycline: with no accompanying symptoms, with mild and with severe symptoms at the beginning.
Time frame: 1 year follow-up
1 secondary outcome
Comparison of subjective symptoms between erythema migrans patients treated with doxycycline and control subjects without a history of Lyme borreliosis.
Time frame: 1 year follow-up
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 24 Mar 2016.
- Individual participant dataSharing planned: Undecided
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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 PhD study chair
UMC 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 Lyme Borreliosis, 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 3 inclusion and 7 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 24 Mar 2016. 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?
Comparing of objective sequelae and post-treatment subjective symptoms in three groups of erythema migrans patients treated with doxycycline: with no accompanying symptoms, with mild and with severe symptoms at the beginning. (time frame: 1 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 24 Mar 2016.