NCT00035269已完成3 期
Linezolid in the Treatment of Penicillin-Resistant Streptococcus Pneumoniae Pneumonia: An Open-Label, Non-Comparator Study
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 230
- 试验地点
- 46
- 主要终点
- To assess the microbiologic efficacy of linezolid in the treatment of patients with pneumonia caused by penicillin-resistant Streptococcus pneumoniae (PRSP).
研究概览
简要总结
This study will treat patients who have a community-acquired pneumonia that is due to a specific bacteria (S. pneumoniae)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have the signs and symptoms of pneumonia, with a chest xray showing a pneumonia.
- •The patient must have S. pneumoniae (a specific bacteria) growing in sputum or blood to continue treatment.
排除标准
- •Patients cannot have taken more than one day of another antibiotic before entering this study.
- •Patients with HIV and a low CD4 count are excluded.
结局指标
主要结局
To assess the microbiologic efficacy of linezolid in the treatment of patients with pneumonia caused by penicillin-resistant Streptococcus pneumoniae (PRSP).
Additionally, microbiologic efficacy will be assessed in all pneumonia patients infected with S pneumoniae SP) and in those infected with penicillin-sensitive (PSSP) and penicillin-intermediate (PISP) S pneumoniae.
次要结局
- To assess clinical efficacy and safety in pneumonia patients infected with S pneumoniae.
研究者
研究点 (46)
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