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The purpose of this study is to compare the efficacy and safety of 15-day ceftriaxone versus 15-day doxycycline treatment in patients with multiple erythema migrans.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MEM-ceftriaxone | Active Comparator |
| |
| MEM-doxycycline | Active Comparator |
| |
| controls | No Intervention | ||
| EM-doxycycline | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ceftriaxone | Drug | intravenously, 2 g, qd, 15 days |
| |
| doxycycline |
| Measure | Description | Time Frame |
|---|---|---|
| Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days. | enrolling 3 years, 1 year follow-up for individual participant: first assessment at baseline | |
| Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days. | second assessment at 14 days postenrollment | |
| Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days. | third assessment at 2 months postenrollment | |
| Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days. | fourth assessment at 6 months postenrollment | |
| Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days. | fifth assessment at 12 months postenrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, or irritability between patients treated with antibiotic for multiple erythema migrans and control subjects without a history of Lyme borreliosis. | enrolling 3 years, 1 year follow-up for individual participant: first assessment at baseline | |
| Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients with solitary versus multiple erythema migrans after antibiotic treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dasa Stupica, MD | Contact | +386 1 522 2110 | cerar.dasa@gmail.com | |
| Franc Strle, MD | Contact | +386 1 522 2610 | franc.strle@kclj.si |
| Name | Affiliation | Role |
|---|---|---|
| Franc Strle, MD | UMC Ljubljana | Study Chair |
| Dasa Stupica, MD | UMC Ljubljana, Department of Infectious Diseases Ljubljana, Slovenia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMC Ljubljana, Department of Infectious Diseases | Recruiting | Ljubljana | 1525 | Slovenia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30075748 | Derived | Veluscek M, Bajrovic FF, Strle F, Stupica D. Doxycycline-induced photosensitivity in patients treated for erythema migrans. BMC Infect Dis. 2018 Aug 3;18(1):365. doi: 10.1186/s12879-018-3270-y. | |
| 29385444 | Derived | Stupica D, Veluscek M, Blagus R, Bogovic P, Rojko T, Cerar T, Strle F. Oral doxycycline versus intravenous ceftriaxone for treatment of multiple erythema migrans: an open-label alternate-treatment observational trial. J Antimicrob Chemother. 2018 May 1;73(5):1352-1358. doi: 10.1093/jac/dkx534. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 3, 2018 | |
| Reset | Oct 18, 2018 | |
| Release | Apr 19, 2019 | |
| Reset | Jun 3, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 3, 2018 | Oct 18, 2018 | |||
| Apr 19, 2019 |
| ID | Term |
|---|---|
| D005929 | Glossitis, Benign Migratory |
| D008193 | Lyme Disease |
| ID | Term |
|---|---|
| D005928 | Glossitis |
| D014060 | Tongue Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D002443 | Ceftriaxone |
| D004318 | Doxycycline |
| ID | Term |
|---|---|
| D002439 | Cefotaxime |
| D002505 | Cephacetrile |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
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| Drug |
orally, 100 mg, bid, 15 days |
|
| erythema migrans patients treated with doxycycline | Other | orally, 100 mg, bid, 15 days |
|
| enrolling 3 years, 1 year follow-up for individual participant: at baseline and at 14 days, 2, 6, and 12 months thereafter |
| Comparison of subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, or irritability between patients treated with antibiotic for multiple erythema migrans and control subjects without a history of Lyme borreliosis. | second assessment at 6 months postenrollment |
| Comparison of subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, or irritability between patients treated with antibiotic for multiple erythema migrans and control subjects without a history of Lyme borreliosis. | third assessment at 6 months postenrollment |
| Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients with solitary versus multiple erythema migrans after antibiotic treatment. | second assessment at 14 days postenrollment |
| Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients with solitary versus multiple erythema migrans after antibiotic treatment. | third assessment at 2 months postenrollment |
| Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients with solitary versus multiple erythema migrans after antibiotic treatment. | fourth assessment at 6 months postenrollment |
| Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients with solitary versus multiple erythema migrans after antibiotic treatment. | fifth assessment at 12 months postenrollment |
| Jun 3, 2019 |
| D016905 |
| Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D001899 | Borrelia Infections |
| D013145 | Spirochaetales Infections |
| D017282 | Tick-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D007769 |
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |