Antibiotic Treatment of Multiple Erythema Migrans

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of Ceftriaxone and Doxycycline for Treatment of Multiple Erythema Migrans

Conditions
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Multiple Erythema Migrans

Intervention / Treatment
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* Drug: ceftriaxone
* Drug: doxycycline
* Other: erythema migrans patients treated with doxycycline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MEM-ceftriaxone<br> | Drug: ceftriaxone<br>* intravenously, 2 g, qd, 15 days<br>|
| Active Comparator: MEM-doxycycline<br> | Drug: doxycycline<br>* orally, 100 mg, bid, 15 days<br>|
| No Intervention: controls<br> | |
| Active Comparator: EM-doxycycline<br> | Other: erythema migrans patients treated with doxycycline<br>* orally, 100 mg, bid, 15 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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erythema migrans, Lyme borreliosis, ceftriaxone treatment, doxycycline treatment, outcome, subjective symptoms