Multiple Erythema Migrans Clinical Trial
Official title:
Comparison of Ceftriaxone and Doxycycline for Treatment of Multiple Erythema Migrans
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.
| Status | Recruiting |
| Enrollment | 500 |
| Est. completion date | October 2017 |
| Est. primary completion date | October 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 15 Years and older |
| Eligibility |
Inclusion Criteria: - multiple erythema migrans in patients > 15 years Exclusion Criteria: - a history of Lyme borreliosis in the past - pregnancy or lactation - immunocompromised status - serious adverse event to doxycycline or beta lactam antibiotic - taking antibiotic with antiborrelial activity within 10 days |
| Country | Name | City | State |
|---|---|---|---|
| Slovenia | UMC Ljubljana, Department of Infectious Diseases | Ljubljana |
| Lead Sponsor | Collaborator |
|---|---|
| University Medical Centre Ljubljana |
Slovenia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | ||
| Primary | 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 | ||
| Primary | 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 | ||
| Primary | 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 | ||
| Primary | 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 | ||
| Secondary | 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 | ||
| Secondary | 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. | enrolling 3 years, 1 year follow-up for individual participant: at baseline and at 14 days, 2, 6, and 12 months thereafter | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | 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 |