NCT01080963已完成4 期
Prospective Randomised Study of Daptomycin as Antibiotic Prophylaxis of Sternal Wound Infections After Median Sternotomy
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
- 650
- 试验地点
- 1
- 主要终点
- Incidence of sternal wound infection is at least 50% lower if Daptomycin is used on top of a standard antibiotic prophylaxis as compared to the standard antibiotic prophylaxis alone
研究概览
简要总结
The purpose of this study is to show that the incidence of sternal wound infections at day 30 after cardiac surgery is 50% lower with the additional use of Daptomycin on top of a standard antibiotic prophylaxis as compared to the standard antibiotic prophylaxis alone.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 18-80
- •written informed consent (IC)
排除标准
- •pregnant and lactating women
- •patients operated for a transplantation
- •patients with a increased myopathy risk
- •patients with a creatinine clearance < 30ml/min; patients on hemodialysis
- •patients after a previous sternotomy
- •treatment with any antibiotics 14 days prior study start
- •treatment with Daptomycin or Cefuroxime within 3 month prior study start
研究组 & 干预措施
Daptomycin
Active Comparator
干预措施: Daptomycin (Drug)
Cefuroxime
Active Comparator
干预措施: Cefuroxime (Drug)
结局指标
主要结局
Incidence of sternal wound infection is at least 50% lower if Daptomycin is used on top of a standard antibiotic prophylaxis as compared to the standard antibiotic prophylaxis alone
时间窗: day 30
次要结局
- Incidence of sternal wound infections at day 30 after cardiac surgery(day 30)
研究者
Martin Strueber
Martin Strueber, MD
Hannover Medical School
研究点 (1)
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