Comparison of Doxycycline and Cefuroxime Axetil in Erythema Migrans

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

509 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-01

Study Completion Date

2007-09-30

Brief Summary

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A European, prospective clinical trial in which doxycycline and cefuroxime axetil were compared in the treatment of adult patients with erythema migrans included a control group to address this question. Evaluations of patients were conducted at baseline, 14 days and 2, 6, and 12 months after enrollment. Control subjects were evaluated at baseline and at 6 and 12 months. Subjective complaints that newly developed or intensified since the onset of erythema migrans or since the date of enrollment for controls were referred to as "new or increased symptoms"(NOIS).

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Detailed Description

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Conditions

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Erythema Chronicum Migrans

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EM doxycycline

patients with EM who received doxycycline

Group Type ACTIVE_COMPARATOR

doxycycline

Intervention Type DRUG

patients received oral doxycycline 100 milgrams bid for 15 days

EM cefuroxime axetil

patients with EM who received cefuroxime axetil

Group Type ACTIVE_COMPARATOR

Cefuroxime Axetil 500Mg Tab

Intervention Type DRUG

patients received cefuroxime axetil 500 milgrams bid for 15 days

controls

control subjects without history of Lyme disease

Group Type PLACEBO_COMPARATOR

control subjects

Intervention Type OTHER

no intervention

Interventions

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doxycycline

patients received oral doxycycline 100 milgrams bid for 15 days

Intervention Type DRUG

Cefuroxime Axetil 500Mg Tab

patients received cefuroxime axetil 500 milgrams bid for 15 days

Intervention Type DRUG

control subjects

no intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* typical solitary erythema migrans as defined by the United States Centers for Disease Control and Prevention. In addition, patients with skin lesion \<5 cm in diameter were also included if they recalled a recent tick bite at the site of the skin lesion, had a symptom-free interval between the bite and the onset of the lesion, and reported an expanding skin lesion prior to diagnosis.

Exclusion Criteria

* Lyme disease previously
* pregnancy or lactation
* immunocompromised
* serious adverse reaction to a beta-lactam or tetracycline drug in the past
* received an antibiotic with known anti-borrelial activity within 10 days
* multiple erythema migrans lesions
* presence of an extracutaneous manifestation of Lyme disease

Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes