Phase 4
Completed N=544
Comparison of Doxycycline and Cefuroxime Axetil for Treatment of Erythema Migrans: Clinical and Microbiological Outcome
Erythema Migrans · Post-Lyme Disease Symptoms
Source: ClinicalTrials.gov NCT01518192 ↗
Enrolled (actual)
544
Serious AEs
0.0%
Results posted
Jan 2012
Primary outcomePrimary: Objective Lyme Disease Manifestations and Post-Lyme Disease Symptoms at 14 Days — 30; 27 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Lyme Disease Manifestations and Post-Lyme Disease Symptoms at 14 Days |
30; 27 | — |
| PRIMARY Adverse Events |
22; 23 | — |
| PRIMARY Objective Lyme Disease Manifestations and Post-Lyme Disease Symptoms at 2 Months |
19; 14 | — |
| PRIMARY Objective Lyme Disease Manifestations and Post-Lyme Disease Symptoms at 6months |
5; 6 | — |
| PRIMARY Objective Lyme Disease Manifestations and Post-Lyme Disease Symptoms at 12 Months |
3; 4 | — |
| SECONDARY New or Increased Symptoms Since Erythema Migrans in Patients and Controls at 6 Months. |
9; 16 | — |
| SECONDARY New or Increased Symptoms Since Erythema Migrans in Patients Controls at 12 Months. |
5; 21 | — |
| SECONDARY Selected Subjective Symptoms in Patients and Control Subjects |
178; 181 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01518192). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.