Zyvox (Linezolid) Special Investigation For Vancomycin-Resistant Enterococci (VRE)(Regulatory Post Marketing Commitment Plan)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 41
- 主要终点
- Number of Participants With Adverse Drug Reactions.
研究概览
简要总结
To collect the efficacy and safety information in subjects who have been treated with Zyvox (linezolid) for vancomycin resistance Enterococcus faecium infection for their appropriate use in daily practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject to whom Zyvox (linezolid) was administered.
- •Infected subject with Vancomycin resistance Enterococcus faecium.
排除标准
- •Infected subject with MRSA and other organism.
研究组 & 干预措施
Zyvox (linezolid)
Patients who have been treated with Zyvox (linezolid).
干预措施: Zyvox (linezolid) (Drug)
结局指标
主要结局
Number of Participants With Adverse Drug Reactions.
时间窗: Baseline to 8 weeks
All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported as adverse events. Definition of adverse drug reaction was treatment related adverse events which were evaluated in company with the causal relationship to the investigational product.
Number of Participants Categorized as Responders (Cure and Improved) to Zyvox (Linezolid) Treatment.
时间窗: Baseline to 8 weeks
Clinical overall effectiveness was evaluated by investigators based on clinical symptoms, laboratory test and investigator judgement, at the end of observation period. Clinical rating (cure/improved/not cured/unable to evaluate) was carried out. Definition of cured was disappearance of clinical symptom and/or Laboratory test abnormality. Definition of improved was improvement in clinical symptoms and/or laboratory test abnormality.
次要结局
- Adverse Drug Reactions Unlisted in Japanese Package Insert.(Baseline to 8 weeks)