Different Duration and Dosing of Amoxicillin in Patients With Erythema Migrans. A Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 510
- 试验地点
- 1
- 主要终点
- Number (frequency) of patients with objective manifestations of Lyme borreliosis or subjective Lyme borreliosis-associated/post-Lyme borreliosis symptoms
研究概览
简要总结
The purpose of this study is to compare the efficacy of different amoxicilline treatment regimens 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
- •erythema migrans
排除标准
- •pregnancy
- •extracutaneous manifestations of Lyme borreliosis
- •immunocompromising state
- •serious adverse event to beta lactam antibiotic
- •receiving antibiotic with antiborrelial activity within 10 days
研究组 & 干预措施
EM-amoxicillin 3 x 10 days
干预措施: EM-amoxicillin 3 x 10 days (Drug)
EM-amoxicillin 3 x 14 days
干预措施: EM-amoxicillin 3 x 14 days (Drug)
EM-amoxicillin 2 x 14 days
干预措施: EM-amoxicillin 2 x 14 days (Drug)
Controls
干预措施: Controls (Other)
结局指标
主要结局
Number (frequency) of patients with objective manifestations of Lyme borreliosis or subjective Lyme borreliosis-associated/post-Lyme borreliosis symptoms
时间窗: One year follow-up
At each visit physical examination wil be performed and clinical signs indicating objective manifestations of Lyme borreliosis, such as erythema migrans, will be searched for and documented. At each visit patients will be asked an open question about any health-related symptoms that had newly developed or worsened since the onset of erythema migrans. If these symptoms will have no other known medical explanation, they will be regarded as Lyme borreliosis-associated constitutional symptoms at enrolment or post-Lyme borreliosis symptoms at follow-up.
次要结局
- Number (frequency) of patients with nonspecific symptoms(One year follow-up)
研究者
Daša Stupica
Principal Investigator
University Medical Centre Ljubljana