CAPRIVI: Community Acquired Pneumonia: Treatment With Avelox® in Hospitalized Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 2,595
- 主要终点
- The primary objective is to evaluate the distribution of the CRB-65 severity index at baseline in hospitalized patients suffering from CAP and to whom moxifloxacin (starting with intravenous administration) was prescribed, in countries from South Eastern
研究概览
简要总结
The aim of this study is to obtain data from hospitalized Community Acquired Pneumonia (CAP) patients on the disease including disease severity, clinical signs and symptoms and measures used for diagnosis in daily routine practice as well as data on Avelox® including information on the use, effectiveness, treatment outcome, safety and tolerability.
As this is a non-interventional observational study, routine clinical practice is observed. The application of medications follows the normal routines and is decided by the treating physician under recognition of the package insert.
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
- •Adult hospitalized patients with a diagnosis of CAP (based on local medical practice) and decision taken by the investigator to treat with moxifloxacin and to start treatment with intravenous administration. The local moxifloxacin product information must be considered.
排除标准
- •Contraindications stated in the local moxifloxacin product information; warnings and precautions must be considered.
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
The primary objective is to evaluate the distribution of the CRB-65 severity index at baseline in hospitalized patients suffering from CAP and to whom moxifloxacin (starting with intravenous administration) was prescribed, in countries from South Eastern
时间窗: At baseline only
次要结局
- Assessment of use of different diagnostic measures in daily routine practice, especially chest radiography and microbiology(7-14 days)
- Determination of the proportion of patients treated with moxifloxacin as antibiotic second-line therapy(7-14 days)
- Assessment of clinical signs and symptoms before and after therapy with moxifloxacin(7-14 days)
- Measurement of moxifloxacin treatment success in terms of effectiveness and outcome(7-14 days)
- Evaluation of safety and tolerability of moxifloxacin in hospitalized CAP patients(7-14 days)