NCT03153267已完成不适用
Duration of Doxycycline Treatment in Patients With Erythema Migrans (EM). A Randomized Clinical Trial.
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Treatment outcome in patients treated for erythema migrans with doxycycline for 7 or 14 days
研究概览
简要总结
The purpose of this study is to compare the efficacy of 7-day versus 14-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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •solitary erythema migrans
排除标准
- •pregnancy or lactation
- •immunocompromised
- •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-7 days doxycycline
Active Comparator
干预措施: Doxycycline 100 MG Oral Tablet bid, 7 days (Drug)
EM-14 days doxycycline
Active Comparator
干预措施: Doxycycline 100 MG Oral Tablet bid, 14 days (Drug)
Controls
Placebo Comparator
干预措施: Controls without a history of lyme disease. (Drug)
结局指标
主要结局
Treatment outcome in patients treated for erythema migrans with doxycycline for 7 or 14 days
时间窗: At 12 months after enrollment.
Objective sequelae and post-treatment subjective new or increased symptoms (NOIS) in patients treated for erythema migrans with doxycycline for 7 or 14 days.
次要结局
- Comparison of nonspecific symptoms in patients with erythema migrans and control subjects(At 12 months after enrollment.)
研究者
Daša Stupica
MD, PhD
University Medical Centre Ljubljana
研究点 (1)
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