Status:
COMPLETED
Comparison of Doxycycline and Cefuroxime Axetil for Treatment of Erythema Migrans: Clinical and Microbiological Outcome
Lead Sponsor:
University Medical Centre Ljubljana
Collaborating Sponsors:
Slovenian Research Agency
Conditions:
Erythema Migrans
Post-Lyme Disease Symptoms
Eligibility:
All Genders
15+ years
Phase:
PHASE4
Brief Summary
Background: * While doxycycline is a standard antibiotic for treatment of erythema migrans in Europe as well as in the USA, the effectiveness of cefuroxime axetil in the treatment of adult patients w...
Detailed Description
Sample size Decisions were based on the following: 1. Number of patients with erythema migrans treated with doxycycline and cefuroxime axetil was determined assuming no difference in treatment outco...
Eligibility Criteria
Inclusion
- patients 15 or more years old
- with typical erythema migrans
- evaluated between 6/06 and 9/06
- evaluated at the Lyme Disease Outpatient Clinic, University Medical Center Ljubljana, Slovenia.
Exclusion
- history of Lyme disease in the past
- pregnancy
- lactation
- immunocompromising condition
- history of a serious adverse reaction to a beta-lactam or tetracycline drug
- receiving an antibiotic with known anti-borrelial activity within 10 days
- multiple erythema migrans lesions or an extracutaneous manifestation of Lyme disease.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
544 Patients enrolled
Trial Details
Trial ID
NCT01518192
Start Date
June 1 2006
End Date
January 1 2009
Last Update
January 25 2012
Active Locations (2)
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1
Institute of Microbiology and Immunology, Medical Faculty, University of Ljubljana
Ljubljana, Slovenia, 1000
2
Department of Infectious Diseases, University Medical Center Ljubljana, Ljubljana, Slovenia
Ljubljana, Slovenia, 1525