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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 7-day versus 14-day doxycycline treatment in patients with erythema migrans.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EM-7 days doxycycline | Active Comparator |
| |
| EM-14 days doxycycline | Active Comparator |
| |
| Controls | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doxycycline 100 MG Oral Tablet bid, 7 days | Drug | Patients will receive doxycycline for 7 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 12 months after enrollment. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 12 months after enrollment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daša Stupica, MD PhD | University Mecical Centre Ljubljana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical centzer Ljubljana | Ljubljana | Slovenia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36209759 | Derived | 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. |
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| ID | Term |
|---|---|
| D015787 | Erythema Chronicum Migrans |
| ID | Term |
|---|---|
| D008193 | Lyme Disease |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D004318 | Doxycycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Doxycycline 100 MG Oral Tablet bid, 14 days | Drug | Patients will receive doxycycline for 14 days. |
|
| Controls without a history of lyme disease. | Drug | No intervention. |
|
| D007239 | Infections |
| D001899 | Borrelia Infections |
| D013145 | Spirochaetales Infections |
| D017192 | Skin Diseases, Bacterial |
| D012874 | Skin Diseases, Infectious |
| D017282 | Tick-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D004890 | Erythema |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |