Study of Lyme Neuroborreliosis: Epidemiology, Manifestations, Diagnostics and Treatment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- The improvement of the clinical condition during the study.
研究概览
简要总结
The main purpose of this study is to determine whether four weeks treatment with oral doxycycline is as equally effective as three weeks treatment with intravenous ceftriaxone in patients with Lyme neuroborreliosis. The other purpose is to improve laboratory diagnostics of Lyme neuroborreliosis and further define the manifestations and epidemiology of the disease in Finland.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •pregnancy and breastfeeding
- •women planning to get pregnant in two months
- •age under 18
- •handicapped persons
- •prisoners
- •use of any antibiotics two weeks before study treatments begins
- •allergy for tetracyclines or cephalosporins
研究组 & 干预措施
Ceftriaxone
Treatment of intravenous ceftriaxone (2 g/day), three weeks
干预措施: Ceftriaxone (Drug)
Doxycycline
Treatment with oral doxycycline (200mg / day), four weeks
干预措施: Doxycycline (Drug)
结局指标
主要结局
The improvement of the clinical condition during the study.
时间窗: 12 months
The clinical condition of participants will be evaluated with visual analogue scale (from 0 to 10, 0=best) by the participants. The VAS scores are collected before the treatment with antibiotics, and 4 months and 12 months after the treatment.
The clinical condition evaluated by the participants after 12 months from the treatment
时间窗: 12 months
The clinical condition is evaluated with VAS by the participants.
次要结局
- Central spinal fluid (CSF) pleocytosis(3 weeks)
- CSF protein concentration(3 weeks)
- CSF CXCL13 concentration(3 weeks)
- CSF lactate level(3 weeks)
研究者
Jarmo Oksi
vs.prof
Turku University Hospital