Special Investigation Of Fluconazole For Pediatric Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 30
- 主要终点
- Number of Participants With Treatment-Related Serious Adverse Events
研究概览
简要总结
To collect the efficacy and safety information of fluconazole on infant subjects related to their appropriate use in daily practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female under age of seven patients who are prescribed fluconazole (Diflucan) for antifungal treatment or prophylaxis administration.
排除标准
- •Subject of seven years or more who have been prescribed fluconazole.
研究组 & 干预措施
fluconazole
Infant Subjects who are treated with fluconazole
干预措施: Fluconazole (Drug)
结局指标
主要结局
Number of Participants With Treatment-Related Serious Adverse Events
时间窗: MAX 13 Weeks
A treatment-related adverse event was any untoward medical occurrence attributed to fluconazole in a participant who received fluconazole. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to fluconazole was assessed by the investigator and sponsor (Pfizer Japan Inc.).
Number of Participants With Treatment-Related Adverse Events
时间窗: MAX 13 Weeks
A treatment-related adverse event was any untoward medical occurrence attributed to fluconazole in a participant who received fluconazole. Relatedness to fluconazole was assessed by the investigator and sponsor (Pfizer Japan Inc.).
Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert
时间窗: MAX 13 Weeks
A treatment-related adverse event was any untoward medical occurrence attributed to fluconazole in a participant who received fluconazole. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to fluconazole was assessed by the investigator and sponsor (Pfizer Japan Inc.).
次要结局
- Clinical Efficacy Rate(MAX 13 Weeks)
- Onset Rate of Deep Mycosis(MAX 13 Weeks)
- Fungi Eradication Rate(MAX 13 Weeks)