NCT01564758已完成不适用
Post Marketing Surveillance on the Efficacy, Safety and Tolerability of Linezolid (Zyvox) in the Treatment of Gram Positive Infections
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 99
- 主要终点
- Number of Participants With Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to determine if Linezolid is safe for adult Filipino patients diagnosed with gram positive infections.
详细描述
The subjects were identified after the physician decided to prescribed the drug to the subject.
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
- •Has clinical diagnosis of of the following, including cases with concurrent bacteremia, when suspected or known to be caused by susceptible strains of anaerobic or aerobic gram positive microorganisms - nosocomial pneumonia, community acquired pneumonia, complicated skin and skin structure infections, uncomplicated skin and skin structure infection, and vancomycin-resistant E. faecium
- •Male or female, 18 years old and above
排除标准
- •Known hypersensitivity
- •Subjects diagnosed with pure gram-negative infection
研究组 & 干预措施
Group 1
Subjects that are diagnosed with gram positive infection
干预措施: Linezolid (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs)
时间窗: Baseline up to End of Treatment (EOT) (Day 10 up to 28)
Any untoward medical occurrence in a participant who received study treatment was considered an AE without regard to possibility of causal relationship.
次要结局
- Number of Participants With Clinical Response(EOT (Day 10 up to 28))
研究者
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