ARTOS - Avelox® in Routine Treatment of Complicated Skin and Skin Structure Infections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 6,127
- 主要终点
- Efficacy: course of severity of infection, course of clinical signs and symptoms, duration until improvement, duration until recovery, duration until wound closure, overall assessment of efficacy by the physician, reuse of Avelox
研究概览
简要总结
This international, prospective, non-interventional, non-controlled observational study obtains data on efficacy, safety and tolerability of Avelox treatment under daily-life treatment conditions. Specifically investigated are the improvement of clinical symptoms and the duration until infection improvement and cure.Any patient with a diagnosis of complicated skin and skin structure infection (cSSSI) treated with Avelox can be documented. The observation period for each subject covers the treatment period with Avelox. For each patient, the physician documents data at an initial visit and one or two follow-up visit(s) in line with routine practice.
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
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient with a diagnosis of complicated skin and skin structure infection (cSSSI) and for whom the decision was made by the attending physician to start treatment with Avelox before inclusion into and independent of the study.
排除标准
- •Exclusion criteria are those specified in 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
Efficacy: course of severity of infection, course of clinical signs and symptoms, duration until improvement, duration until recovery, duration until wound closure, overall assessment of efficacy by the physician, reuse of Avelox
时间窗: last documented follow-up visit, according to the respective praxis routine
次要结局
- Adverse events collection(during entire study course, according to the respective praxis routine)
- Overall assessment of tolerability by the physician(last documented follow-up visit, according to the respective praxis routine)