GIANT - Greatest International Antiinfective Trial With Avelox®
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 50,000
- 主要终点
- Evaluation of impact of AECB on the patient and the community as well as effect and safety of a treatment with moxifloxacin tablets in daily life clinical practice
研究概览
简要总结
The observation period for each patient covered an initial treatment period with Avelox® plus optional 2 long-term follow-up periods (6 and 12 months).For each patient, the physician documented data at any initial visit (baseline) and at least one short-term follow-up visit (=initial treatment period).Optionally, long-term follow-ups (6 and 12 months) were documented, and a patient questionnaire was filled in.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients with diagnosis of AECB and decision taken by the investigator to prescribe moxifloxacin
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
Evaluation of impact of AECB on the patient and the community as well as effect and safety of a treatment with moxifloxacin tablets in daily life clinical practice
时间窗: During documentation at baseline and at at least one short-term follow-up visit; at maximum two short-term (within ca. 14 days) and two long-term follow-up visits (after ca. 6 and 12 months).
次要结局
- Course of symptom relief(During documentation of up to two short-term follow-up visits (within ca. 14 days))
- Speed of return to normal daily life activities(During documentation of the last short-term follow-up visit (after ca. 14 days))
- Adverse events collection(Throughout the entire study, whenever Adverse Events occur)
- Evaluation of frequency of new exacerbations(During documentation of up to two long-term follow-up visits (after ca. 6 and 12 months))
- Progression of chronic respiratory disease(During documentation of up to two long-term follow-up visits (after ca. 6 and 12 months))