NCT01163994Unknown不适用
Comparison of Ceftriaxone and Doxycycline for Treatment of Multiple Erythema Migrans
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days.
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of 15-day ceftriaxone versus 15-day doxycycline treatment in patients with multiple 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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •multiple erythema migrans in patients > 15 years
排除标准
- •a history of Lyme borreliosis in the past
- •pregnancy or lactation
- •immunocompromised status
- •serious adverse event to doxycycline or beta lactam antibiotic
- •taking antibiotic with antiborrelial activity within 10 days
研究组 & 干预措施
MEM-ceftriaxone
Active Comparator
干预措施: ceftriaxone (Drug)
MEM-doxycycline
Active Comparator
干预措施: doxycycline (Drug)
EM-doxycycline
Active Comparator
干预措施: erythema migrans patients treated with doxycycline (Other)
结局指标
主要结局
Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days.
时间窗: fifth assessment at 12 months postenrollment
次要结局
- Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients with solitary versus multiple erythema migrans after antibiotic treatment.(fifth assessment at 12 months postenrollment)
- Comparison of subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, or irritability between patients treated with antibiotic for multiple erythema migrans and control subjects without a history of Lyme borreliosis.(third assessment at 6 months postenrollment)
研究者
Franc Strle
M.D., PhD
University Medical Centre Ljubljana
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Effect of Intravenous Ceftriaxone and Oral Doxycycline for Lyme NeuroborreliosisLyme NeuroborreliosisNCT00138801Sorlandet Hospital HF120
已完成
不适用
Comparison of Doxycycline and Cefuroxime Axetil in Erythema MigransErythema Chronicum MigransNCT03584919University Medical Centre Ljubljana509
Unknown
不适用
Doxycycline and Ceftriaxone in Suspected Early Lyme NeuroborreliosisSuspected Early Lyme NeuroborreliosisNCT00942006University Medical Centre Ljubljana200
已完成
3 期
Comparison of ciprofioxacin - Doxycycline and rifampin – Doxycycline regimens in preventing brucellosis relapseBrucellosis.A23.0, A23BrucellosisIRCT2012080310482N1Arak University of Medical Sciences90
已完成
2 期
The effect of cefotaxime on improvement of pediatric dysenteryDysentery.Gastroenteritis and colitis of unspecified originIRCT2016102211145N18Vice Chancellor of Research and Technology, Kashan University of Medical Sciences100