NCT00343135已完成4 期
An Open, Non-comparative Study to Evaluate the Efficacy and Safety of AUGMENTIN 1gm (875mg Amoxicillin/125mg Clavulanic Acid) po q 12 Hours in the Treatment of Uncomplicated Skin and Soft Tissue Infections in Pakistan
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 195
- 试验地点
- 1
- 主要终点
- Clinical response at 10 - 14 days post therapy
研究概览
简要总结
Study to evaluate the effects of AUGMENTIN 1gm in the treatment of Skin and Soft tissue infections
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •having diagnosed uncomplicated soft tissue infection (e.g furuncle, cellulitis)
- •has given freely documented consent.
排除标准
- •antibiotics
- •have renal or hepatic insufficiency
- •systemic toxicity
- •pregnancy
- •lactation
- •hypersensitivity to penicillin or Beta-lactam antibiotics
研究组 & 干预措施
ARM 1
Experimental
干预措施: amoxicillin/clavulanate potassium 1gm (Drug)
结局指标
主要结局
Clinical response at 10 - 14 days post therapy
时间窗: 10 - 14 days
次要结局
- Clinical response at on-therapy evaluation visit (2 - 4 days following initiation of therapy and 48 - 96 hours post therapy) Bacteriological response at (2 - 4 days following initiation of therapy, 48 - 96 hours post therapy, 10 - 14 days post therapy)(2 - 4 days)
研究者
研究点 (1)
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