NCT00645203已完成2 期
An Open-Label, Safety and Efficacy Study of Cefdinir Oral Suspension, 25 mg/kg Once Daily, in Pediatric Subjects With Acute Otitis Media
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 447
- 主要终点
- Bacteriological Response
研究概览
简要总结
To evaluate the safety and efficacy of cefdinir oral suspension in children between 6 months and 4 years of age, with acute otitis media, who are at risk of persistent or recurrent otitis media.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female children between 6 months and 4 years of age
- •Weight does not exceed 40 kg
- •Clinical diagnosis is acute otitis media
- •Have evidence of middle ear fluid
- •At risk for persistent or recurrent otitis media
- •Generally in good health
排除标准
- •Sensitivity or allergy to penicillins or cephalosporins or inability to take oral medications
- •Presence of tympanostomy tubes, ventilation tube or perforated tympanic membrane, in either ear
- •Treatment with any anti-infective agent within 3 days prior to the study or treatment with a long-acting injectable antimicrobial agent (e.g. , penicillin G benzathine) within 4 weeks prior to the study
- •Concomitant infection, that requires additional antimicrobial therapy
- •Presence of a disease, complicating factor (e.g., mastoiditis), or structural abnormality that would preclude evaluation of the patient's therapeutic response
研究组 & 干预措施
1
Other
干预措施: cefdinir (Drug)
结局指标
主要结局
Bacteriological Response
时间窗: 30 days
Clinical response
时间窗: 30 days
Change in the otoscopic findings
时间窗: 30 days
次要结局
- Adverse events assessment(45 days with follow-up to a satisfactory conclusion)
- Physical exam; Vital signs; Use of concomitant medications(59 days)
- Laboratory evaluations(30 days)
研究者
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