VICTOR - Avelox® i.v. in Acute Exacerbations of Chronic Bronchitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 1,206
- 主要终点
- clinical cure rate:clinical cure was defined as disappearance of acute signs and symptoms
研究概览
简要总结
This study is a local, prospective, open-label, company-sponsored, non interventional, multi-center study. Patients documented must suffer from an acute exacerbation of chronic bronchitis and take at least one dose of Moxifloxacin injection.The primary objective is to obtain clinical effectiveness and safety data of Moxifloxacin injection in the treatment of acute exacerbations of chronic bronchitis in patients in whom Moxifloxacin was routinely prescribed. The secondary objective is to find out the possible correlation between the risk factors (sex, smoking, number of previous exacerbations, etc) and AECB, the different treatment effectiveness according to Anthonisen classification. This study will also collect the data of pathogens by sputum culture and the defervescence time of Moxifloxacin injection in treating Acute Exacerbations of Chronic Bronchitis (AECB).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients at least 18 years of age with a diagnosis of AECB treated with Moxifloxacin injection with/without sequential tablet treatment
排除标准
- •Exclusion criteria must be read in conjunction with the local product information
研究组 & 干预措施
Group 1
干预措施: Moxifloxacin (Avelox, BAY12-8039) (Drug)
结局指标
主要结局
clinical cure rate:clinical cure was defined as disappearance of acute signs and symptoms
时间窗: up to 21 days
次要结局
- Time to cure: time when symptoms are disappeared after Moxifloxacin treatment(up to 21 days)
- Improvement time: time when patients feel improvemen(up to 21 days)
- Time of patients recover from fever(up to 21 days)
- Clinical efficacy rate of Moxifloxacin(up to 21 days)