English Efficacy and Tolerance of 4 Weeks of Tedizolid in Prosthetic Joint Infections Treated With Implant Removal
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Investigator-assessed incidence of local signs infection at 6 months after tedizolid
研究概览
简要总结
To evaluate the efficacy of 4 weeks of 200 mg/24h of tedizolid for prosthetic join infections caused by tedizolid susceptible microorganisms treated with implant removal in one or two stages at 6 months of followup after stopping tedizolid treatment.
详细描述
To evaluate the efficacy of 4 weeks of 200 mg/24h of tedizolid for prosthetic join infections caused by tedizolid susceptible microorganisms treated with implant removal in one or two stages at 6 months of followup after stopping tedizolid treatment.
Secondary objectives:
Evaluate the efficacy of tedizolid at 12 months of follow-up; evaluate the rate of gastrointestinal adverse events with tedizolid; determine the rate of haematological abnormalities during tedizolid treatment and; in case of two-stage exchange, the rate of positive cultures during reimplantation.
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
- 否
入选标准
- •Male or female older than 18 years who accept and sign the informed consent.
- •Infection signs onset more than 3 months after index arthroplasty.
- •Diagnostic of chronic (≥3 weeks of clinical symptoms) hip or knee prosthetic joint infection according to MSIS criteria *(Parvizi J, Gherke T. Definition of peri-prosthetic joint infection. J Arthroplasty 2014; 29: 1331)
- •Infection due to a tedizolid susceptible microorganism.
- •Surgical approach: one or two - stage exchange of all implant components.
- •Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
排除标准
- •Patients with a prosthetic joint infection with negative cultures.
- •Patients who undergo debridement without removing the prosthesis or only partially removed
- •≥15 days of other antibiotic treatment before starting tedizolid
- •Life expeancy ≤ 1 year.
- •Previous enrollment in this protocol.
- •Hypersensitivity to tedizolid or any formulation excipients.
- •Concurrent use of another investigational medication within 30 days of study entry.
- •Women who are pregnant or breast-feeding
研究组 & 干预措施
Sivextro arm
200 mg milligram per day during 4 weeks
干预措施: Sivextro 200 milligrams Oral Tablet (Drug)
结局指标
主要结局
Investigator-assessed incidence of local signs infection at 6 months after tedizolid
时间窗: 6 months
incidence or absence of local signs of infection at the 6 months after tedizolid treatment.
次要结局
- Incidence of Adverse Events at 12 months after ending tedizolid treatment(12 months)
- Incidence of positive blood cultures during reimplantation on the two stage exchange cases.(0, 7 days and months 1, 2, 6, 12)
研究者
Anna Cruceta
Project manager
Fundacion Clinic per a la Recerca Biomédica