Special Drug Use Investigation of Ciproxan® Injection in Pediatrics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 48
- 主要终点
- Number of musculoskeletal adverse events.
研究概览
简要总结
The objective in this study is collecting post-marketing information on the safety and efficacy of Ciproxan injection under the routine clinical practice.
详细描述
This company-sponsored study is an one-arm, prospective, and, cohort-observational study in pediatrics (less than 15 years old) administered Ciproxan injection. All patients in the contracted institute should be enrolled into this study. Consequently 45 cases will be is planned to be enrolled in three-year period Target population is pediatrics with a diagnosis of complicated cystitis, pyelonephritis, cystic fibrosis, or anthrax infected by ciprofloxacin-active microorganisms, i.e. Bacillus anthracis, Escherichia coli, Pseudomonas aeruginosa. The treatment should be performed based on the product label in Japan. The standard observation will be performed until the last date of the treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Female and male pediatric patients (less than 15 years old) with a diagnosis of complicated cystitis, pyelonephritis, cystic fibrosis, or anthrax infected by ciprofloxacin-active microorganisms, i.e. Bacillus anthracis, Escherichia coli, Pseudomonas aeruginosa.
- •Patients for whom the decision to initiate treatment with Ciproxan injection was made as per investigator's routine treatment practice.
排除标准
- 未提供
研究组 & 干预措施
BAYQ3939
Pediatrics patients treated with Ciproxan injection in daily clinical practice.
干预措施: Cipro (Ciprofloxacin, BAYQ3939) (Drug)
结局指标
主要结局
Number of musculoskeletal adverse events.
时间窗: Up to 12 months
次要结局
- Existence of Bacillus anthracis or Escherichia coli or Pseudomonas aeruginosa in urine(Y/N)(At week 6)
- Number of participants with adverse events as measure of safety and tolerability(At week 4)
- Efficacy(Up to 2 weeks)
- Number of participants with adverse events based on abnormal laboratory measurements(At week 4)