NCT02860767已完成不适用
Dosing of Antibiotics (Serum and Periprosthetic Tissues) During Reimplantation of Infected Knee and Hip Prostheses
Tourcoing Hospital3 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年8月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Primary outcome measure was the evaluation of concentrations in serum and periprosthetic tissues of antibiotic agents used as empirical therapy during reimplantation of the infected prosthesis
研究概览
简要总结
The purpose of the study is to evaluate the concentrations of antibiotics used as empirical treatment in serum and periprosthetic tissues during reimplantation of infected hip and knee prostheses
详细描述
The purpose of the study is to evaluate the concentrations of antibiotics (daptomycin, vancomycin, cefotaxime, ceftriaxone, cefepime) in serum and periprosthetic tissues(bone and synovial joint) used as empirical treatment during reimplantation of infected hip and knee prostheses (1-stage or 2-stage management).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Adult patients (aged of 18 years or more) who undergo reimplantation surgery for infected hip or knee prosthesis (performed in 1 or 2-stage(s)), and for whom referral physicians plans to use an empirical antibiotic therapy including cefotaxime, ceftriaxone, cefepime, daptomycin, or vancomycin.
排除标准
- •Patients with multiple prosthetic joint infections, or with curative antibiotic therapy ongoing within two weeks or less prior to surgery, or for whom an antibiotic prophylaxis is decided by referral for the reimplantation surgery, or for whom an antibiotic-loaded cement containing the same antibiotic chosen for empirical therapy after reimplantation was used in case of 2-stage exchange
结局指标
主要结局
Primary outcome measure was the evaluation of concentrations in serum and periprosthetic tissues of antibiotic agents used as empirical therapy during reimplantation of the infected prosthesis
时间窗: 1 day
次要结局
- Secondary outcome will analyze the ratio of antibiotic concentration in serum and prosthetic tissues to minimum inhibitory concentration of the concerned antibiotic for the pathogen(s) identified in intraoperative samples(1 day)
研究者
研究点 (3)
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