NCT00229112已完成3 期
A Prospective, Multicenter, Double-Blind With In-House Blinding, Randomized, Comparative Study to Evaluate the Efficacy, Safety, and Tolerability, of Ertapenem Versus Piperacillin/Tazobactam in the Treatment of Diabetic Foot Infections in Adults.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 400
- 主要终点
- Clinical Cure/Improvement at discontinuation of IV antibiotic therapy.
研究概览
简要总结
This study will compare the efficacy, safety and tolerability of intravenous ertapenem versus another intravenous antibiotic in the treatment of moderate to severe diabetic foot infections.
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
- Double (Participant, Investigator)
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
- •Type 1 or 2 Diabetes Mellitus treated with diet or medication
- •Clinically or microbiologically documented foot infection below the knee
- •Osteomyelitic bone must be removed within 48 hours of study entry
排除标准
- •Uncomplicated skin infections
- •Infected burn wounds
- •Necrotizing fascitis
- •Wounds with gangrene that cannot be removed with debridement
- •Infections of prosthetic materials
- •Foreign materials that can not be removed by surgical debridement
- •Patients with another antibiotic 3 days prior to enrollment without evidence of treatment failure and presence of a positive culture
- •Insufficient blood flow to the limb requiring a revascularization procedure
结局指标
主要结局
Clinical Cure/Improvement at discontinuation of IV antibiotic therapy.
次要结局
- Clinical Cure: 1. Day 5 of IV antibiotic therapy; 2.10 days after completion of all antibiotic therapy.
研究者
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