An observational study in Lyme Disease, Erythema Migrans and Elderly Infection, sponsored by University Medical Centre Ljubljana. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-23.
Sponsored by University Medical Centre Ljubljana · Observational
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.
97 studies on the registry are indexed under Lyme Disease; 26 are open to participants now.
This study's enrollment of 1,220 is above the median of 400 across 42 observational studies indexed under Lyme Disease.
Browse Lyme Disease studies →University Medical Centre Ljubljana is the lead sponsor of 296 studies on the registry; 72 are open to participants now.
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young (18-44 years), middle-aged (45-64 years) and elderly 65 or more years) patients with erythema migrans
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Antibiotics
Drug: Antibiotics
Other: no intervention
Drug: Antibiotics
Patients were treated with antibiotics for Lyme disease.
controls were not given antibiotics
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Study point: at 12 months post-enrollment.
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).
Time frame: Study points will be: at enrollment, at 6, and at 12 months post-enrollment
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Jan 2006 to primary completion in Dec 2018, 155 months.
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This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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