A European, prospective clinical trial in which doxycycline and cefuroxime axetil were compared in the treatment of adult patients with erythema migrans included a control group to address this question. Evaluations of patients were conducted at baseline, 14 days and 2, 6, and 12 months after enrollment. Control subjects were evaluated at baseline and at 6 and 12 months. Subjective complaints that newly developed or intensified since the onset of erythema migrans or since the date of enrollment for controls were referred to as "new or increased symptoms"(NOIS).
Full Title of Study: “Comparison of Doxycycline and Cefuroxime Axetil in Patients With Erythema Migrans”
- Study Type: Interventional
- Study Design
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: September 30, 2007
- Drug: doxycycline
- patients received oral doxycycline 100 milgrams bid for 15 days
- Drug: Cefuroxime Axetil 500Mg Tab
- patients received cefuroxime axetil 500 milgrams bid for 15 days
- Other: control subjects
- no intervention
Arms, Groups and Cohorts
- Active Comparator: EM doxycycline
- patients with EM who received doxycycline
- Active Comparator: EM cefuroxime axetil
- patients with EM who received cefuroxime axetil
- Placebo Comparator: controls
- control subjects without history of Lyme disease
Clinical Trial Outcome Measures
- Change from Baseline in Objective Manifestations and Subjective New or Increased Symptoms (NOIS) in Patients Treated for Erythema Migrans With Doxycycline or Cefuroxime Axetil for 15 Days
- Time Frame: One year follow-up (follow-up time points at 14 days, 2 months, 6 months, and 12 months after enrolment)
- At each visit patients were examined and asked about the presence of any symptoms that newly developed or had worsened since erythema migrans. If such symptoms had no other medical explanation they were regarded as new or increased symptoms (NOIS). Complete response was defined as absence of any manifestations of Lyme borreliosis, with return to pre-Lyme borreliosis health status. Partial response was defined as presence of NOIS. Failure was defined as presence of objective manifestations of Lyme borreliosis or persistence of Borrelia burgdorferi sensu lato in skin at the site of the previous erythema migrans.
- Number of Patients (at 12 Months After Treatment With Doxycycline or Cefuroxime Axetil for 15 Days for Erythema Migrans) and Number of Control Subjects (Without a History of Lyme Borreliosis) With Nonspecific Symptoms.
- Time Frame: 12 months after treatment
- 12 months after treatment patients and controls were asked to complete a written questionnaire asking whether they had had any of 8 nonspecific symptoms (fatigue, arthralgias, headache, myalgias, paresthesias, concentration difficulties, or irritability) within the preceding week. For both patients and controls, the severity of each individual symptom was graded by the subject on a 10-cm visual analog scale (10 = most severe).
Participating in This Clinical Trial
- typical solitary erythema migrans as defined by the United States Centers for Disease Control and Prevention. In addition, patients with skin lesion <5 cm in diameter were also included if they recalled a recent tick bite at the site of the skin lesion, had a symptom-free interval between the bite and the onset of the lesion, and reported an expanding skin lesion prior to diagnosis.
- Lyme disease previously
- pregnancy or lactation
- serious adverse reaction to a beta-lactam or tetracycline drug in the past
- received an antibiotic with known anti-borrelial activity within 10 days
- multiple erythema migrans lesions
- presence of an extracutaneous manifestation of Lyme disease
Gender Eligibility: All
Minimum Age: 15 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- University Medical Centre Ljubljana
- Provider of Information About this Clinical Study
- Principal Investigator: Daša Stupica, Principal Investigator – University Medical Centre Ljubljana
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