NCT01244581已完成3 期
Oral Amoxicillin-clavulanate in Treating Acute Otitis Media in Children: Randomized Double-blind Placebo-controlled Study Including Daily Monitoring With Tympanometry
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Time (days) to disappearance of middle ear effusion
研究概览
简要总结
The purpose of the study is to assess the efficacy of amoxicillin-clavulanate in treating acute otitis media in children. The primary end point is time to disappearance of middle ear effusion which monitored by daily tympanometry performed by families and study physicians.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with acute otitis media
排除标准
- •Amoxicillin allergy
- •Tympanic membrane perforation
- •Tympanostomy tubes (current)
- •Complication of acute otitis media such as mastoiditis
研究组 & 干预措施
Amoxicillin-clavulanate
Experimental
Oral amoxicillin-clavulanate 40 mg/kg/day divided in two daily doses for 7 days
干预措施: Amoxicillin-clavulanate (Drug)
Placebo
Placebo Comparator
干预措施: Amoxicillin-clavulanate (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Time (days) to disappearance of middle ear effusion
时间窗: Within 60 days
Disappearance of middle ear effusion is defined as the first day of receiving a normal tympanogram (A-curve) in tympanometry.
次要结局
- Time (days) to disappearance of pain(Within 60 days)
研究者
Terhi Tapiainen
M.D., Ph.D.
University of Oulu
研究点 (2)
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