NCT00653172已完成2 期
A Double-Blind, Multicenter, Randomized, Double Dummy, Three-Arm Parallel-Group Comparative Study of the Efficacy, Safety and Tolerance of Oral NXL 103 Versus Oral Comparator in the Treatment of Community-Acquired Pneumonia in Adults
Novexel Inc60 个研究点 分布在 8 个国家目标入组 302 人开始时间: 2007年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 302
- 试验地点
- 60
- 主要终点
- Evaluate Clinical outcome
研究概览
简要总结
The purpose of this study is to compare the efficacy, safety and tolerance of 2 different dose levels of oral NXL103 with oral comparator in the treatment of community acquired pneumonia in adults
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Community acquired pneumonia
排除标准
- •severe CAP
- •respiratory infections attributed to sources other than community acquired bacterial infection
- •concomitant pulmonary disease
- •history of hypersensitivity to study medication, macrolide or beta lactam antibiotics
研究组 & 干预措施
1
Experimental
NXL103
干预措施: NXL103 (Drug)
3
Active Comparator
干预措施: comparator (Drug)
2
Experimental
NXL103
干预措施: NXL103 (Drug)
结局指标
主要结局
Evaluate Clinical outcome
时间窗: early follow up visit (day 14 to 21)
次要结局
- Evaluate bacteriological outcome(early follow up visit (day 14 to 21))
- Evaluate safety(first dose, throughout treatment, and to follow up visit)
研究者
研究点 (60)
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