Different Amoxicillin Treatment Regimens in Erythema Migrans Patients

Study Overview
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Brief Summary
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The purpose of this study is to compare the efficacy of different amoxicilline treatment regimens in patients with erythema migrans.

Official Title
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Different Duration and Dosing of Amoxicillin in Patients With Erythema Migrans. A Randomized Clinical Trial.

Conditions
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Erythema Migrans

Intervention / Treatment
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* Drug: EM-amoxicillin 3 x 10 days
* Drug: EM-amoxicillin 3 x 14 days
* Drug: EM-amoxicillin 2 x 14 days
* Other: Controls


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: erythema migrans Exclusion Criteria: pregnancy extracutaneous manifestations of Lyme borreliosis immunocompromising state serious adverse event to beta lactam antibiotic receiving antibiotic with antiborrelial activity within 10 days

Ages Eligible for Study
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Minimum Age: 18 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: EM-amoxicillin 3 x 10 days<br> | Drug: EM-amoxicillin 3 x 10 days<br>* Patients will receive amoxicillin 500 milligram tid for 10 days<br>|
| Active Comparator: EM-amoxicillin 3 x 14 days<br> | Drug: EM-amoxicillin 3 x 14 days<br>* Patients will receive amoxicillin 500 milligram tid for 14 days<br>|
| Active Comparator: EM-amoxicillin 2 x 14 days<br> | Drug: EM-amoxicillin 2 x 14 days<br>* Patients will receive amoxicillin 500 milligram bid for 14 days<br>|
| Other: Controls<br> | Other: Controls<br>* No intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |