NCT01815541已完成2 期
Administration of Subcutaneous Teicoplanin in the Treatment of Osteoarticular Infections: Tolerance Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- measure of tolerance
研究概览
简要总结
This is a biomedical research, prospective, mono centric, tolerance study Of the administration of subcutaneous teicoplanin in the treatment of osteoarticular infections.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient over 18 years
- •Inpatient orthopedic surgery
- •Achieved a bone and joint infection documented gram + (staphylococci golden coagulase-negative staphylococci, enterococci, streptococci)
- •Bacteria resistant to lincosamides, quinolones and rifampicin
- •Bacteria susceptible to teicoplanin (MIC ≤ 4 mg / L)
- •Balanced patient teicoplanin administered intravenously (2 successive doses between 30 and 40 mg / mL)
排除标准
- •Patient not affiliated to the social security
- •Pregnant and lactating women
- •Known hypersensitivity to teicoplanin (rash, ...)
- •Patients with a central catheter or an implantable chamber
- •Patient hemodialysis
- •Patient has another participant biomedical research on a drug to prevent drug interactions
- •Patient minor
- •Patient major protected (protection of the court, wardship, trusteeship)
- •Patient admitted for emergency or incapable of consent
研究组 & 干预措施
teicoplanin
Experimental
this group receive the teicoplanin
干预措施: teicoplanin (Drug)
结局指标
主要结局
measure of tolerance
时间窗: 6 weeks
The frequencies of adverse reactions at the injection site SC will be measured to assess the local tolerance of teicoplanin by SC.
次要结局
未报告次要终点
研究者
研究点 (1)
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