NCT00644943已完成4 期
A Comparison of the Safety and Efficacy of Cefdinir Oral Suspension Versus Amoxicillin/Clavulanate in Pediatric Subjects With Acute Otitis Media
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 425
- 主要终点
- Clinical Cure Rate
研究概览
简要总结
The primary objective is to compare the safety and efficacy of cefdinir oral suspension, 7 mg/kg/day ql2hrs for 5 days, to amoxicillin/clavulanate oral suspension 45 mg/kg/day (based on amoxicillin component), in divided doses, q12h for 10 days, in children between 6 months and 6 years of age, with AOM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 6 Months 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis, documented by medical history and physical examination, is acute otitis media <=1 week
- •Clinical signs and symptoms include >=1 of the following: ear pain; ear fullness, decreased hearing, or discharge from the external auditory canal (following acute perforation of the tympanic membrane).
- •At least two of the following conditions are present in at least one ear: bulging tympanic membrane, which may have redness; loss of the normal light reflex and tympanic membrane landmarks and abnormal tympanic membrane mobility on biphasic pneumatic otoscopy, due to the presence of pus or fluid behind it and edema of the tympanic membrane.
- •Have evidence of middle ear fluid demonstrated by acoustic reflect-tympometry.
- •Generally in good health based on medical history, vital signs, physical exam, and historical laboratory results
排除标准
- •Previous enrollment in this study.
- •Enrollment in any other investigational study using unapproved products or unapproved doses, including investigational vaccines in the previous four weeks prior to study start.
- •Hypersensitivity reactions to cefdinir, other cephalosporins, penicillins, other drugs, and/or sensitivity to multiple allergens.
- •Presence of tympanostomy tubes or otitis externa at Evaluation
- •Systemic treatment with any anti-infective agent within 7 days (14 days for azithromycin) prior to Evaluation 1 or during the study.
- •Treatment with a long-acting injectable antimicrobial agent (e.g., penicillin G benzathine) within 4 weeks prior to study drug administration.
- •Concomitant infection, that requires additional antimicrobial therapy.
- •Evidence of chronic, suppurative otitis media.
- •Evidence of a physiologic, anatomic, or immunologic defect, which would interfere with resolution of this episode of acute otitis media.
- •Presence of a disease, complicating factor (e.g., mastoiditis), or structural abnormality that would preclude evaluation of the subject's therapeutic response.
- •Known, severe renal impairment (i.e., creatinine clearance < 30 mUmid1.73 m2).
- •History of Augmentin-associated cholestatic jaundicehepatic dysfunction.
研究组 & 干预措施
1
Active Comparator
干预措施: cefdinir (Omnicef) (Drug)
2
Active Comparator
干预措施: amoxicillin (Drug)
结局指标
主要结局
Clinical Cure Rate
时间窗: 9 days
次要结局
- Sustained Clinical Cure Rate(28 days)
研究者
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