NCT00649831已完成3 期
Azithromycin (Zithromax®) 5 Days Versus Amoxicillin-Clavulanic Acid (Augmentin®): Multicentre, Randomised, Open-Label Study To Compare The Clinical Efficacy And Safety Of Azithromycin With Those Of Amoxicillin-Clavulanic Acid In Patients Presenting With An Exacerbation Of Chronic Bronchitis
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
- Pfizer
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- To assess clinical efficacy (clinical recovery or clinical failure)
研究概览
简要总结
This study compared the clinical efficacy and safety of azithromycin with that of amoxicillin-clavulanic acid, in patients between the ages of 35 and 75 years, presenting with an exacerbation of chronic bronchitis.
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
- 36 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Outpatients presenting with an exacerbation of chronic bronchitis including: chronic bronchitis with obstructive respiratory disorders documented by a forced expiratory volume of below 80% and higher than 35% of the theoretical value, within the previous 12 months; and thought to be of infectious origin
排除标准
- •Exclusion Criteria:
- •Patient not presenting with the associated signs of an exacerbation
- •Patient presenting with clinical signs suggestive of pneumonopathy at inclusion
- •Patient requiring hospitalisation in intensive care
研究组 & 干预措施
Group 2
Active Comparator
干预措施: Amoxicillin/clavulinic acid (Drug)
Group 1
Active Comparator
干预措施: Azithromycin (Drug)
结局指标
主要结局
To assess clinical efficacy (clinical recovery or clinical failure)
时间窗: Day 30
次要结局
- Bacteriological monitoring (a descriptive analysis of streptococci in the bacterial flora and their sensitivity to antibiotics at the different collections of sputum)(continuous)
- Number of exacerbations(Day 30 to Day 90)
研究者
研究点 (1)
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