Special Drug Use Investigation for CLAVAMOX® (Amoxicillin/Clavulanate) Pediatrics Dry Syrup (Every Indication Excluded Otitis Media)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 363
- 主要终点
- The number of incidence of adverse events in Japanese pediatric patients, with diseases other than otitis media, treated with amoxicillin and clavulanate based on prescribing information
研究概览
简要总结
This post-marketing surveillance study of CLAVAMOX® was designed to collect and assess the information on proper use, such as safety and efficacy, under actual use conditions, targeting pediatric Japanese patients with diseases (superficial skin infection, deep skin infection, lymphangitis, lymphadenitis, chronic pyoderma, pharyngitis, laryngitis, tonsillitis, acute bronchitis, cystitis, pyelonephritis) other than otitis media.
("CLAVAMOX" is a trademark of the GlaxoSmithKline group of companies.)
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric subjects with diseases of superficial skin infection, deep skin infection, lymphangitis, lymphadenitis, chronic pyoderma, pharyngitis, laryngitis, tonsillitis, acute bronchitis, cystitis and pyelonephritis
排除标准
- •Not applicable
研究组 & 干预措施
Pediatrics patients prescribed amoxicillin and clavulanate
Pediatrics patients prescribed amoxicillin and clavulanate for treatment of diseases other than otitis media during study period
干预措施: Amoxicillin and clavulanate (Drug)
结局指标
主要结局
The number of incidence of adverse events in Japanese pediatric patients, with diseases other than otitis media, treated with amoxicillin and clavulanate based on prescribing information
时间窗: 2 months
Clinical symptoms after treatment with amoxicillin and clavulanate
时间窗: 2 months
次要结局
未报告次要终点