NCT01045902已完成3 期
Prospective, Multi-center, Randomized, Non-blind Trial to Assess the Efficacy and Safety of Moxifloxacin Versus Sulbactam/Ampicillin in the Treatment of Pulmonary Abscess and Aspiration Pneumonia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 139
- 主要终点
- Adverse events occuring after first application of study medication up to the test of cure visit for non-serious adverse events
研究概览
简要总结
The purpose of this trial is to determine the efficacy and safety of Moxifloxacin in comparison to Sulbactam/Ampicillin in the treatment of pulmonary abscesses and aspiration pneumonia.
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
- None
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
- •Male or female patients aged 18 years or above
- •The primary diagnosis is community or hospital acquired primary pulmonary abscess or aspiration pneumonia, requiring initial parenteral treatment
排除标准
- •Known hypersensitivity to fluoroquinolones and/or ß-lactams
- •Patients with mechanical ventilation lasting more than 48 hours prior to enrollment, with poststenotic pneumonia, infarction pneumonia, pulmonary tuberculosis, lung abscess/pneumonia with concomitant endocarditis
研究组 & 干预措施
Arm 1
Experimental
干预措施: Avelox (Moxifloxacin, BAY12-8039) (Drug)
Arm 2
Active Comparator
干预措施: Sulbactam/Ampicillin (Drug)
结局指标
主要结局
Adverse events occuring after first application of study medication up to the test of cure visit for non-serious adverse events
时间窗: Up to 30 days after end of treatment with study medication for serious adverse events
次要结局
- Clinical Response(Regulary doing i.v. treatment)
研究者
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