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Comparison of Doxycycline and Cefuroxime Axetil for Treatment of Erythema Migrans: Clinical and Microbiological Outcome

NCT01518192 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 544

Last updated 2012-01-25

Study results available
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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.

Conditions

  • Erythema Migrans
  • Post-Lyme Disease Symptoms

Interventions

DRUG

doxycycline

100 mg bid; 15 days

DRUG

cefuroxime axetil

500 mg bid; 15 days

Sponsors & Collaborators

  • Slovenian Research Agency

    collaborator OTHER

  • University Medical Centre Ljubljana

    lead OTHER

Principal Investigators

  • Daša Cerar, MD · Department of Infectious Diseases, University Medical Center Ljubljana, Ljubljana, Slovenia

  • Franc Strle, MD · Department of Infectious Diseases, University Medical Center Ljubljana, Ljubljana, Slovenia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2007-11-30
Completion
2009-01-31

Countries

  • Slovenia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01518192 on ClinicalTrials.gov