Doxycycline in Therapy of Erythema Migrans - do the Accompanying Symptoms Influence the Outcome?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Comparing of objective sequelae and post-treatment subjective symptoms in three groups of erythema migrans patients treated with doxycycline: with no accompanying symptoms, with mild and with severe symptoms at the beginning.
研究概览
简要总结
The investigators will compare the outcome of three groups of erythema migrans patients treated with doxycycline: a group without any accompanying symptoms, with mild symptoms and with severe symptoms that require lumbar puncture.
详细描述
Patients with erythema migrans treated with doxycycline for two weeks will be followed-up for one year (at 2 weeks, 2, 6 and 12 months) clinically and also by filling in the questionnaire to assess the presence of certain symptoms. Also the control group of their friends or relatives without a history of Lyme borreliosis will be included. The presence of their (unspecific) symptoms will also be recorded by the questionnaire at the time of enrollment and at 6 and 12 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •presence of erythema migrans
- •>15 years old
- •informed consent
排除标准
- •pregnancy
- •lactation
- •multiple erythema migrans
- •already treated with antibiotic for this episode of Lyme borreliosis
- •allergy to doxycycline
- •treatment with drugs with known interactions with doxycycline
- •cerebrospinal fluid pleocytosis
研究组 & 干预措施
no symptoms
patients with erythema migrans and no additional newly onset symptoms treated with doxycycline
干预措施: Doxycycline (Drug)
mild symptoms
patients with erythema migrans and mild unspecific newly onset symptoms treated with doxycycline
干预措施: Doxycycline (Drug)
severe symptoms-lumbar puncture
patients with erythema migrans and newly onset intense "neurologic" symptoms with lumbar puncture performed, treated with doxycycline
干预措施: Doxycycline (Drug)
结局指标
主要结局
Comparing of objective sequelae and post-treatment subjective symptoms in three groups of erythema migrans patients treated with doxycycline: with no accompanying symptoms, with mild and with severe symptoms at the beginning.
时间窗: 1 year follow-up
次要结局
- Comparison of subjective symptoms between erythema migrans patients treated with doxycycline and control subjects without a history of Lyme borreliosis.(1 year follow-up)
研究者
Franc Strle
M.D., PhD
University Medical Centre Ljubljana