CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 544 enrolled
Drug / intervention
doxycycline +1 moredrug
Likely dose
doxycycline 100 mgfrom record
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Search/NCT01518192
NCT01518192Phase 4Completed

Risk Factors for Failure of Erythema Migrans Treatment - Comparison of Doxycycline and Cefuroxime Axetil for Treatment of Adult Patients With Erythema Migrans: Clinical and Microbiological Outcome.

University Medical Centre Ljubljana·interventional·Posted Jan 25, 2012·Updated Jan 25, 2012

In Brief

A Phase 4 clinical trial evaluating doxycycline and cefuroxime axetil for Erythema Migrans and Post-Lyme Disease Symptoms. Completed, enrolled 544 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSlovenia

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 25, 2012
Enrollment StartJun 1, 2006
Primary CompletionNov 1, 2007
Study CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 14.4 years ago

Interventions

doxycyclinedrug

100 mg bid; 15 days

cefuroxime axetildrug

500 mg bid; 15 days