Ciprofloxacin Special Drug Use Investigation - To Investigate the Safety and Efficacy in Patients With Ciprofloxacin iv Administration Without Dilution
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 704
- 主要终点
- Incidence of adverse drug reactions (ADRs) and serious adverse events (AEs)
研究概览
简要总结
This study is a post-marketing surveillance in Japan to investigate the safety especially focusing on injection site adverse events and efficacy in patients with Ciprofloxacin iv administration without dilution in the daily practice.It is a local prospective and observational study of patients who have received Ciproxan intravenously for sepsis, secondary skin infections followed by superficial burn, post-surgical or post-traumatic, pneumonia, peritonitis, cholecystitis, cholangitis, anthrax. A total of 500 patients are to be enrolled and assessed during the period of treatment with Ciproxan.
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
- 7 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- The mentioned bellow patients caused by the following bacteria which are sensitive to this drug: Indicated microorganisms:Staphylococcus, Enterococcus, Bacillus anthracis, Escherichia coli, Klebsiella , Enterobacter, Pseudomonas aeruginosa, Legionella. Indications: Sepsis, Secondary skin infections (superficial burn, operative wounds, trauma), Pneumonia, Peritonitis, Cholecystitis, Cholangitis, Anthrax
- •The patients treated with this drug without dilution due to strict restriction of fluid intake.
- •In hospitalized patients who retain consciousness ,and at the same time who are able to report (such as vascular pain) side effects..
排除标准
- •Patients who are contraindicated based on the product label.
研究组 & 干预措施
Group 1
Patient treated with Ciproxan without dilution treatment in daily clinical practice
干预措施: Cipro (Ciprofloxacin, BAYQ3939) (Drug)
结局指标
主要结局
Incidence of adverse drug reactions (ADRs) and serious adverse events (AEs)
时间窗: After 8 days
Clinical efficacy by four grade (Response, Minor Response, No Response, and Indeterminable) at an investigator discretion
时间窗: After 8 days
次要结局
- ADR incidence rates classified by patient's background factors(After 8 days)
- Efficacy rate calculated with Response and Minor Response considered as responder(After 8 days)
- Efficacy rates classified by patient's background factors(After 8 days)