NCT00276042已完成2 期
Prospective, Randomized, Investigator-Blind Trial to Evaluate the Bacteriologic Eradication, Safety and Tolerability, and Pharmacokinetics of Different Dosages of Faropenem Medoxomil BID for 10 Days in the Treatment of Acute Otitis Media
Replidyne3 个研究点 分布在 2 个国家目标入组 328 人开始时间: 2006年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 328
- 试验地点
- 3
- 主要终点
- To evaluate bacteriologic efficacy
研究概览
简要总结
The study will be conducted in infants and children with acute otitis media, 6 months to less than 7 years old, in Costa Rica and Israel. The primary objective of this trial will be to describe bacteriologic efficacy in those with initial culture positive specimens with different dosages of faropenem
详细描述
The study will be conducted in infants and children with acute otitis media, 6 months to <7 years old, in Costa Rica and Israel. Faropenem is to be used as therapy for both simple and complicated AOM.
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
- Double
入排标准
- 年龄范围
- 6 Months 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute Otis Media
排除标准
- •Any antibiotic for more than 24 hours (unless a treatment failure) within 7 days prior to enrollment
结局指标
主要结局
To evaluate bacteriologic efficacy
次要结局
- To describe investigator assessment of clinical response
研究者
研究点 (3)
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