Duration of Antibiotic Treatment of Erythema Migrans. A Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 306
- 试验地点
- 1
- 主要终点
- Objective Sequelae and Post-treatment Subjective New or Increased Symptoms (NOIS)in Patients Treated for Erythema Migrans With Doxycycline for 10 or 15 Days.
研究概览
简要总结
The purpose of this study is to compare the efficacy of 15-day versus 10-day doxycycline treatment in patients with erythema migrans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •solitary erythema migrans in patients > 15 years
排除标准
- •a history of Lyme borreliosis in the past
- •pregnancy or lactation
- •immunocompromised status
- •serious adverse event to doxycycline
- •taking antibiotic with antiborrelial activity within 10 days
- •multiple erythema migrans or extracutaneous manifestations of Lyme borreliosis
研究组 & 干预措施
EM-10 days doxycycline
干预措施: doxycycline (Drug)
EM-doxycycline 15 days
干预措施: doxycycline (Drug)
controls
干预措施: placebo (Drug)
结局指标
主要结局
Objective Sequelae and Post-treatment Subjective New or Increased Symptoms (NOIS)in Patients Treated for Erythema Migrans With Doxycycline for 10 or 15 Days.
时间窗: 1 year follow-up
At each visit patients were examined and asked about the presence of any symptoms that newly developed/had worsened since erythema migrans. If such symptoms had no other medical explanation they were regarded as new or increased symptoms (NOIS). Complete response=absence of any manifestations of Lyme borreliosis, with return to pre-Lyme borreliosis health status. Partial response=presence of NOIS. Failure=presence of objective manifestations of Lyme borreliosis or persistence of B. burgdorferi sensu lato in skin at the site of the previous erythema migrans.
次要结局
- Number of Patients (at 6 Months After Treatment With Doxycycline for 10 or 15 Days for Erythema Migrans) and Number of Control Subjects (Without a History of Lyme Borreliosis) With Nonspecific Symptoms.(6 months after treatment)
研究者
Franc Strle
M.D., PhD
University Medical Centre Ljubljana