NCT00942006Unknown不适用
Doxycycline and Ceftriaxone in Patients With Suspected Early Lyme Neuroborreliosis and Normal CSF Cell Count.
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Objective sequelae and post-treatment subjective symptoms in patients treated for suspected early Lyme neuroborreliosis with normal CSF cell count with doxycycline or ceftriaxone for 14 days.
研究概览
简要总结
The investigators will compare doxycycline and ceftriaxone in treatment of patients with suspected early Lyme neuroborreliosis and normal CSF cell count. The study hypothesis is that the efficacy and adverse effects of both antibiotics are comparable.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age >15 years
- •erythema migrans in 4 months period before neurologic symptoms
- •normal CSF cell count
- •absence of more defined clinical symptoms or signs for CNS involvement (radicular pain, meningeal signs, peripheral facial palsy).
排除标准
- •pregnancy
- •lactation
- •allergy on doxycycline and ceftriaxone
- •immune deficiency.
研究组 & 干预措施
LNB-doxycycline
Active Comparator
干预措施: doxycycline (Drug)
LNB-ceftriaxone
Active Comparator
干预措施: ceftriaxone (Drug)
结局指标
主要结局
Objective sequelae and post-treatment subjective symptoms in patients treated for suspected early Lyme neuroborreliosis with normal CSF cell count with doxycycline or ceftriaxone for 14 days.
时间窗: 1 year follow-up
次要结局
未报告次要终点
研究者
研究点 (1)
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