Duration of Antibiotic Treatment of Erythema Migrans

Study Overview
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Brief Summary
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The purpose of this study is to compare the efficacy of 15-day versus 10-day doxycycline treatment in patients with erythema migrans.

Official Title
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Duration of Antibiotic Treatment of Erythema Migrans. A Randomized Clinical Trial.

Conditions
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Erythema Chronicum Migrans

Intervention / Treatment
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* Drug: doxycycline
* Drug: doxycycline
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: solitary 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 taking antibiotic with antiborrelial activity within 10 days multiple erythema migrans or extracutaneous manifestations of Lyme borreliosis

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EM-10 days doxycycline<br> | Drug: doxycycline<br>* doxycycline 100 mg bid, 10 days<br>|
| Active Comparator: EM-doxycycline 15 days<br> | Drug: doxycycline<br>* doxycycline 100 mg bid, 15 days<br>|
| Placebo Comparator: controls<br> | Drug: placebo<br>* control subjects without a history of Lyme borreliosis<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 New or Increased Symptoms (NOIS)in Patients Treated for Erythema Migrans With Doxycycline for 10 or 15 Days. | At each visit patients were examined and asked about the presence of any symptoms that newly developed/had worsened since erythema migrans. If such symptoms had no other medical explanation they were regarded as new or increased symptoms (NOIS). Complete response=absence of any manifestations of Lyme borreliosis, with return to pre-Lyme borreliosis health status. Partial response=presence of NOIS. Failure=presence of objective manifestations of Lyme borreliosis or persistence of B. burgdorferi sensu lato in skin at the site of the previous erythema migrans. | 1 year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients (at 6 Months After Treatment With Doxycycline for 10 or 15 Days for Erythema Migrans) and Number of Control Subjects (Without a History of Lyme Borreliosis) With Nonspecific Symptoms. | 6 months after treatment patients and controls were asked to complete a written questionnaire asking whether they had had any of 14 nonspecific symptoms (fatigue, malaise, arthralgias, headache, myalgias, pain in the spine, paresthesias, dizziness, nausea, insomnia, sleepiness, forgetfulness, concentration difficulties, or irritability) within the preceding week. For both patients and controls, the severity of each individual symptom was graded by the subject on a 10-cm visual analog scale (10 = most severe). | 6 months after treatment | 

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