Assessment of the Safety and Efficacy of Ciproxan-I.V. in Daily Clinical Practice - Analysis Results From a Post-marketing Surveillance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 3,274
- 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, and it is a local prospective and observational study of patients who have received Ciproxan intravenously as a first-line treatment for sepsis, secondary skin infections followed by superficial burn, post-surgical or post-traumatic, pneumonia, peritonitis, cholecystitis, cholangitis, anthrax. The objective of this study is to assess safety and efficacy of Ciproxan in daily clinical practice. A total of 3,000 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
- •Patients who received Ciproxan as a first-line treatment were eligible for the study, among those with sepsis, secondary infection due to trauma, burn, or surgical wound, pneumonia, peritonitis, cholecystitis, cholangitis, and anthrax as the indications of this drug.
排除标准
- •Patients who are contraindicated based on the product label.
研究组 & 干预措施
Group 1
干预措施: 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 9 days
Clinical efficacy by four grade (Response, Minor Response, No Response, and Indeterminable) at an investigator discretion
时间窗: After 9 days
次要结局
- ADR incidence rates classified by patient's background factors(After 9 days)
- Efficacy rates classified by patient's background factors(After 9 days)
- Efficacy rate calculated with Response and Minor Response considered as responder(After 9 days)