Comparison of Doxycycline and Cefuroxime Axetil in Patients With Erythema Migrans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 509
- 主要终点
- 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
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Lyme disease previously
- •pregnancy or lactation
- •immunocompromised
- •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
研究组 & 干预措施
EM doxycycline
patients with EM who received doxycycline
干预措施: doxycycline (Drug)
EM cefuroxime axetil
patients with EM who received cefuroxime axetil
干预措施: Cefuroxime Axetil 500Mg Tab (Drug)
controls
control subjects without history of Lyme disease
干预措施: control subjects (Other)
结局指标
主要结局
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
时间窗: 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.
次要结局
- 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.(12 months after treatment)
研究者
Daša Stupica
Principal Investigator
University Medical Centre Ljubljana