A National, Multicenter, Non-comparative Study Evaluating the Efficacy of the Combination of Levofloxacin (500 mg) and Rifampicin (600 or 900 mg Depending on Weight) Administered Once Daily by Oral Route, as Replacement of Empirical Antibiotic Therapy Given Intravenously With a Total Duration of 6 Weeks of the Antibiotic Therapy, in the Treatment of OsteoArticular Prosthetic Infections (OAPI), With a Two-stage Revision of the Prosthesis.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Microbiological success defined as the percentage of patients with negative peri-operative bacteriological samples and the absence of clinical, biological or radiological signs of infection.
研究概览
简要总结
The primary objective is: to assess the microbiological success of the combination of levofloxacin and rifampicin, administered for 32 to 37 days, as oral replacement therapy of an empirical antibiotic therapy of a maximum of 5 to 10 days given intravenously, in the treatment of OsteoArticular Prosthetic Infections (OAPI), with a two-stage revision of the prosthesis.
The secondary endpoints are:
- To assess the rate of clinical failure 12 months after the reimplantation of the prosthesis.
- To assess the joint mobility function score 12 months after the reimplantation of the prosthesis.
- To assess the safety of the combination of levofloxacin and rifampicin.
- To investigate prognostic factors for success after the end of treatment and at 12 months after the reimplantation of the prosthesis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Levofloxacin and Rifampicin
干预措施: Levofloxacin (HR355) and Rifampicin Therapy (Drug)
结局指标
主要结局
Microbiological success defined as the percentage of patients with negative peri-operative bacteriological samples and the absence of clinical, biological or radiological signs of infection.
时间窗: During the reimplantation of the new prosthesis i.e. 15 days to 3 months after the end of treatment
次要结局
- Clinical failure(12 months after reimplantation of the prosthesis)
- Joint mobility function score(12 months after reimplantation of the prosthesis)