通用名称

fidaxomicin

儿科标签批准日期

2020/1/24 0:00:00

特定指示/秒

Treatment of Clostridioides difficile-associated diarrhea (CDAD) in pediatric patients 6 months to 17 years

标签更改摘要

- Safety and effectiveness of the treatment of CDAD have been established in pediatric patients 6 months to 17 years. - Use of fidaxomicin in these age groups is supported by evidence from adequate and well-controlled trials of fidaxomicin in adults with CDAD and pharmacokinetic, safety and efficacy data from pediatric trials. - Adverse reactions are similar to those observed in adults. - Safety and effectiveness have not been established in pediatric patients younger than 6 months. - Information on dosing, Adverse Reactions, PK parameters and clinical trials. - New oral suspension. - Postmarketing study.

治疗类别

Anti-Infective

立法类型

BPCA Only

产品说明书链接

书号

2.0 1.0

研究年龄

1 MONTHS - 17 YEARS 11 MONTHS - 17 YEARS

学习类型

Efficacy,Safety Safety,Pharmacokinetic,Tolerability

研究设计

Multicenter,Randomized,Active Comparator,Single-Blind,Parallel Group,Phase 3 Multicenter,Open-Label,Phase 2

登记的患者

148 38

患者分析

142 38

中心的数量

40 11

国家数量

10 2

西班牙裔拉美裔/拉丁裔总计

17 4

非西班牙裔/非拉丁裔总人数

113 34

总数#种族不明

12 0

亚裔学生总数

2 1

黑人总数

8 2

白人总数

116 33

夏威夷或太平洋岛民总数

0 0

美洲印第安人/阿拉斯加本地人总数

0 1

其他种族总计

5 1

未知种族总数

11 0

国家

United States,Belgium,Canada,France,Germany,Hungary,Italy,Poland,Romania,Spain United States,Canada