Comparison of Doxycycline and Cefuroxime Axetil for Treatment of Erythema Migrans: Clinical and Microbiological Outcome
Information source: University Medical Centre Ljubljana
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Erythema Migrans; Post-Lyme Disease Symptoms
Intervention: doxycycline (Drug); cefuroxime axetil (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University Medical Centre Ljubljana Official(s) and/or principal investigator(s): Daša Cerar, MD, Principal Investigator, Affiliation: Department of Infectious Diseases, University Medical Center Ljubljana, Ljubljana, Slovenia Franc Strle, MD, Study Chair, Affiliation: Department of Infectious Diseases, University Medical Center Ljubljana, Ljubljana, Slovenia
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.
Clinical Details
Official title: 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.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Objective Lyme Disease Manifestations and Post-Lyme Disease Symptoms at 14 DaysAdverse Events Objective Lyme Disease Manifestations and Post-Lyme Disease Symptoms at 2 Months Objective Lyme Disease Manifestations and Post-Lyme Disease Symptoms at 6months Objective Lyme Disease Manifestations and Post-Lyme Disease Symptoms at 12 Months
Secondary outcome: New or Increased Symptoms Since Erythema Migrans in Patients and Controls at 6 Months.New or Increased Symptoms Since Erythema Migrans in Patients Controls at 12 Months. Selected Subjective Symptoms in Patients and Control Subjects
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 outcome will be detected
(non-inferiority testing).
2. The decision for a larger sample sizes than needed for 1. was done with the intention
to evaluate the secondary outcome measure, i. e., to assess the difference between the
frequency of new or increased symptoms in patients treated for early Lyme disease and
the occurrence of the same symptoms in control subjects.
1. We assumed that the outcomes in the two treatment groups will be comparable and
that the patients could be combined for further analysis.
2. To obtain a control group from the same geographical area, each patient was asked
if she or he had a family member or friend who was within 5 years of her or his
age and who was without a history of Lyme borreliosis. These persons were
approached by a short written explanation of the investigation, containing also a
request for their participation. We assumed that we will be able to get a
corresponding control person not for all but for approximately 80-90% of patients.
3. Under the assumption that approximately 15% of an estimated 200 patients would
have new or increased symptoms at >6 months after enrollment into the study, a
control group of 165 subjects would be sufficient to detect a >10 percentage point
lower rate of new or increased symptoms in controls compared with patients at the
0. 05 level (2-sided) with >90% power. To comply with drop outs at different time
points we assessed that 280 patients and 230 controls should be included at
baseline.
Eligibility
Minimum age: 15 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.
Locations and Contacts
Department of Infectious Diseases, University Medical Center Ljubljana, Ljubljana, Slovenia, Ljubljana 1525, Slovenia
Institute of Microbiology and Immunology, Medical Faculty, University of Ljubljana, Ljubljana 1000, Slovenia
Additional Information
Starting date: June 2006
Last updated: December 18, 2011
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