NCT02937181Unknown4 期
Antibiotic Prophylaxis With Ceftaroline for Type II and II Open Fractures: a Phase 4, Open-label, Prospective Clinical Trial
Olayemi Osiyemi MD1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Rate of fracture site infection at 30 days between ceftaroline and historical hospital rate
研究概览
简要总结
Prospective look at antibiotic prophylaxis with Ceftaroline in patients with type II and III open fractures
详细描述
Determine if antibiotic prophylaxis with Ceftaroline in patients with type II and III open fractures is a safe and effective alternative to standard combination therapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 是
入选标准
- •male or female >= 18 years old
- •complete an informed consent
- •patients are diagnosed with a type II or III open fracture
排除标准
- •allergy to beta-lactam antibiotics prior to screening
- •prior to enrollment: patients received 3 or more doses of antibiotic prophylaxis
- •pregnant female
- •inability to provide consent
研究组 & 干预措施
open fractures type II and III
Experimental
Every patients will receive Ceftaroline in an open label, single arm
干预措施: Ceftaroline (Drug)
结局指标
主要结局
Rate of fracture site infection at 30 days between ceftaroline and historical hospital rate
时间窗: 30 days
次要结局
- Incidence of acute kidney injury(30 days)
研究者
Olayemi Osiyemi MD
President/
Triple O Research Institute PA
研究点 (1)
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