Lyme DiseaseNCT03371563
Erythema Migrans in Elderly
An observational study of Lyme Disease and Erythema Migrans, run by University Medical Centre Ljubljana.
Trial summary
The investigators will focus on elderly patients with early Lyme borreliosis with the aim of assessing clinical course, serological response and treatment outcome of the disease as compared to younger adults. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lyme Disease, Erythema Migrans, Elderly Infection
- What is being tested?
- Antibiotics
- How many people
- 1,220 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2006to 31 Dec 2018
- How long will I take part?
- 1 Year
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: young (18-44 years), middle-aged (45-64 years) and elderly 65 or more years) patients with erythema migrans
Who may be able to join
- erythema migrans
Who cannot join
- pregnancy or lactation
- immunocompromised
- taking antibiotic with antiborrelial activity within 10 days
- received <10 days of antibiotic therapy for erythema migrans
- had an intercurrent episode of Lyme borreliosis during follow-up
About this study
Official title: Clinical Course, Serologic Response and Long-term Outcome in Elderly Patients With Early Lyme Borreliosis
The investigators will focus on elderly patients with early Lyme borreliosis with the aim of assessing clinical course, serological response and treatment outcome of the disease as compared to younger adults. Furthermore, the investigators will compare the prevalence of nonspecific symptoms among patients and among age-matched controls without a history of Lyme borreliosis.
- Conditions
- Lyme Disease, Erythema Migrans, Elderly Infection
- Being tested
- Antibiotics, no intervention
- 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.
AntibioticsDrug
Patients were treated with antibiotics for Lyme disease.
no interventionOther
controls were not given antibiotics
| Study group | Role | What they receive |
|---|---|---|
| elderly patients | Not described Receives: Drug: Antibiotics | |
| middle-aged patients | Not described Receives: Drug: Antibiotics | |
| controls | Not described Receives: Other: no intervention | |
| young patients | Not described Receives: Drug: Antibiotics |
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 postenrollment in patients treated for erythema migrans
At follow-up at 14 days patients were examined physically and were asked an open question about health-related symptoms. Symptoms that had newly develop or worsened since the onset of the multiple erythema migrans and which will had no other known medical explanation were 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 was 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 postenrollment in patients treated for erythema migrans with doxycycline for 7 or 14 days
At follow-up at 2 months patients were examined physically and were asked an open question about health-related symptoms. Symptoms that hed newly develop or worsened since the onset of the erythema migrans and which will had no other known medical explanation were regarded as post-Lyme symptoms.
Complete response to treatment was 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 was 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 postenrollment in patients treated for erythema migrans
At follow-up at 6 months patients were examined physically and were asked an open question about health-related symptoms. Symptoms that had newly develop or worsened since the onset of the erythema migrans and which had no other known medical explanation were regarded as post-Lyme symptoms. Complete response to treatment was defined as a return to pre-Lyme health status. Partial response was 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 was 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 postenrollment in patients treated for erythema migrans
At 12 months patients were examined physically and were asked an open question about health-related symptoms.
Symptoms that had develop or worsened since the onset of the erythema migrans and which had no other known medical explanation were regarded as post-Lyme symptoms. Complete response to treatment was defined as a return to pre-Lyme health status. Partial response was 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 was 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 erythema migrans and control subjects
Patients completed 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 completed 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 graded 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 posted13 Dec 2017
- Study start1 Jan 2006
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lyme DiseaseStudies of the same condition, open and under way.
- 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
- 1,220 participants (actual)
- Target duration
- 1 Year
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03371563
- Sponsor's protocol ID
- EM-elderly
- Status last verified
- Apr 2019
- First submitted
- 8 Dec 2017
- Last updated
- 23 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Course, Serologic Response and Long-term Outcome in Elderly Patients With Early Lyme Borreliosis
- ClinicalTrials.gov ID
- NCT03371563
- Acronym / sponsor ID
- EM-elderly
- Conditions
- Lyme Disease, Erythema Migrans, Elderly Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,220 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 1 Jan 2006 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 13 Dec 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 investigators will focus on elderly patients with early Lyme borreliosis with the aim of assessing clinical course, serological response and treatment outcome of the disease as compared to younger adults. Furthermore, the investigators will compare the prevalence of nonspecific symptoms among patients and among age-matched controls without a history of Lyme borreliosis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| elderly patients | – | Drug: Antibiotics |
| middle-aged patients | – | Drug: Antibiotics |
| controls | – | Other: no intervention |
| young patients | – | Drug: Antibiotics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- young (18-44 years), middle-aged (45-64 years) and elderly 65 or more years) patients with erythema migrans
Key inclusion criteria (1 listed)
- erythema migrans
Key exclusion criteria (5 listed)
- pregnancy or lactation
- immunocompromised
- taking antibiotic with antiborrelial activity within 10 days
- received <10 days of antibiotic therapy for erythema migrans
- had an intercurrent episode of Lyme borreliosis during follow-up
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 |
|---|---|---|
| AntibioticsPatients were treated with antibiotics for Lyme disease. | Drug | elderly patients, middle-aged patients, young patients |
| no interventioncontrols were not given antibiotics | Other | controls |
Primary outcome
Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 14 days postenrollment in patients treated for erythema migrans
Time frame: Study point: at 14 days post-enrollment.
At follow-up at 14 days patients were examined physically and were asked an open question about health-related symptoms. Symptoms that had newly develop or worsened since the onset of the multiple erythema migrans and which will had no other known medical explanation were 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 was interpreted as failure.
Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 2 months postenrollment in patients treated for 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 were examined physically and were asked an open question about health-related symptoms. Symptoms that hed newly develop or worsened since the onset of the erythema migrans and which will had no other known medical explanation were regarded as post-Lyme symptoms. Complete response to treatment was 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 was be interpreted as failure.
Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 6 months postenrollment in patients treated for erythema migrans
Time frame: Study point: at 6 months post-enrollment.
At follow-up at 6 months patients were examined physically and were asked an open question about health-related symptoms. Symptoms that had newly develop or worsened since the onset of the erythema migrans and which had no other known medical explanation were regarded as post-Lyme symptoms. Complete response to treatment was defined as a return to pre-Lyme health status. Partial response was 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 was interpreted as failure.
Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 12 months postenrollment in patients treated for erythema migrans
Time frame: Study point: at 12 months post-enrollment.
At 12 months patients were examined physically and were asked an open question about health-related symptoms. Symptoms that had develop or worsened since the onset of the erythema migrans and which had no other known medical explanation were regarded as post-Lyme symptoms. Complete response to treatment was defined as a return to pre-Lyme health status. Partial response was 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 was 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 erythema migrans and control subjects
Time frame: Study points will be: at enrollment, at 6, and at 12 months post-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 23 Apr 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Lyme Disease and Erythema Migrans, run by University Medical Centre Ljubljana.
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 23 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 14 days postenrollment in patients treated for erythema migrans (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 23 Apr 2019.