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| Name | Class |
|---|---|
| University of Ljubljana School of Medicine, Slovenia | OTHER |
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The purpose of this study is to compare the efficacy of different amoxicilline treatment regimens in patients with erythema migrans.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EM-amoxicillin 3 x 10 days | Active Comparator | amoxicillin for 10 days |
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| EM-amoxicillin 3 x 14 days | Active Comparator | amoxicillin for 14 days |
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| Controls | Other | controls without Lyme borreliosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EM-amoxicillin 3 x 10 days | Drug | Patients will receive amoxicillin 500 milligram tid for 10 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number (frequency) of patients with objective manifestations of Lyme borreliosis or subjective Lyme borreliosis-associated/post-Lyme borreliosis symptoms | At each visit physical examination wil be performed and clinical signs indicating objective manifestations of Lyme borreliosis, such as erythema migrans, will be searched for and documented. At each visit patients will be asked an open question about any health-related symptoms that had newly developed or worsened since the onset of erythema migrans. If these symptoms will have no other known medical explanation, they will be regarded as Lyme borreliosis-associated constitutional symptoms at enrolment or post-Lyme borreliosis symptoms at follow-up. | One year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Number (frequency) of patients with nonspecific symptoms | At each visit patients will be asked to complete a written questionnaire asking whether they had had any of eight non-specific symptoms (fatigue, arthralgias, headache,myalgias, paraesthesias, memory difficulties, concentration difficulties and irritability) within the preceding week. | One year follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daša Stupica, MD PhD | Contact | +38631689324 | dasa.stupica@kclj.si | |
| Maša Velušček, MD | Contact | +38631332904 | masa.veluscek@kclj.si |
| Name | Affiliation | Role |
|---|---|---|
| Daša Stupica, MD PhD | Department of Infectious Diseases, University Medical Centre Ljubljana, Slovenia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Centre Ljubljana | Recruiting | Ljubljana | Slovenia |
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| ID | Term |
|---|---|
| D005929 | Glossitis, Benign Migratory |
| ID | Term |
|---|---|
| D005928 | Glossitis |
| D014060 | Tongue Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| EM-amoxicillin 3 x 14 days | Drug | Patients will receive amoxicillin 500 milligram tid for 14 days |
|
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| Controls | Other | No intervention. |
|
| University Medical Centre Ljubljana | Not yet recruiting | Ljubljana | Slovenia |
|