Comparison of Doxycycline and Cefuroxime Axetil for Treatment of Erythema Migrans: Clinical and Microbiological Outcome
Status:
Completed
Trial end date:
2009-01-01
Target enrollment:
Participant gender:
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 with erythema migrans has been assessed only in the USA where the causative
agent of Lyme disease is Borrelia burgdorferi, but not in Europe where the main
etiologic agents are B. afzelii and B. garinii.
- Controversy exists over the significance and even the existence of post-Lyme disease
symptoms because of the high rate of similar background symptoms in the general
population.
Purpose:
The two main purposes of this European, prospective clinical trial in which doxycycline and
cefuroxime axetil are compared in the treatment of adult patients with erythema migrans and
which included a control group to address the significance of post-Lyme disease symptoms are:
- To assess and compare the effectiveness of doxycycline and cefuroxime axetil in the
treatment of erythema migrans using clinical and bacteriological criteria
(noninferiority testing approach), and
- to compare the frequency of post-Lyme disease symptoms in adult patients treated for EM
with antibiotics and the frequency of similar symptoms in control subjects without Lyme
disease.