Doxycycline in Therapy of Erythema Migrans

Study Overview
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Brief Summary
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The investigators will compare the outcome of three groups of erythema migrans patients treated with doxycycline: a group without any accompanying symptoms, with mild symptoms and with severe symptoms that require lumbar puncture.

Detailed Description
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Patients with erythema migrans treated with doxycycline for two weeks will be followed-up for one year (at 2 weeks, 2, 6 and 12 months) clinically and also by filling in the questionnaire to assess the presence of certain symptoms. Also the control group of their friends or relatives without a history of Lyme borreliosis will be included. The presence of their (unspecific) symptoms will also be recorded by the questionnaire at the time of enrollment and at 6 and 12 months.

Official Title
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Doxycycline in Therapy of Erythema Migrans - do the Accompanying Symptoms Influence the Outcome?

Conditions
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Lyme Borreliosis

Intervention / Treatment
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* Drug: Doxycycline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: presence of erythema migrans >15 years old informed consent Exclusion Criteria: pregnancy lactation multiple erythema migrans already treated with antibiotic for this episode of Lyme borreliosis allergy to doxycycline treatment with drugs with known interactions with doxycycline cerebrospinal fluid pleocytosis

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| no symptoms<br>patients with erythema migrans and no additional newly onset symptoms treated with doxycycline | Drug: Doxycycline<br>* 100 mg PO bid, 14 days<br>* Other names: Doxy;|
| mild symptoms<br>patients with erythema migrans and mild unspecific newly onset symptoms treated with doxycycline | Drug: Doxycycline<br>* 100 mg PO bid, 14 days<br>* Other names: Doxy;|
| severe symptoms-lumbar puncture<br>patients with erythema migrans and newly onset intense neurologic symptoms with lumbar puncture performed, treated with doxycycline | Drug: Doxycycline<br>* 100 mg PO bid, 14 days<br>* Other names: Doxy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparing of objective sequelae and post-treatment subjective symptoms in three groups of erythema migrans patients treated with doxycycline: with no accompanying symptoms, with mild and with severe symptoms at the beginning. |  | 1 year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of subjective symptoms between erythema migrans patients treated with doxycycline and control subjects without a history of Lyme borreliosis. |  | 1 year follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Outcome, Lyme borreliosis, Erythema migrans, Doxycycline, Subjective symptoms