EUCTR2018-002465-18-ES进行中（未招募）1 期
Efficacy and tolerance of 4 weeks of tedizolid in prosthetic joint infections treated with implant removal - PROTEDI
Fundació Clínic per a la Recerca Biomèdica0 个研究点目标入组 20 人开始时间: 2019年8月9日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Male or female older than 18 years who accept and sign the informed consent.
- •2. Infection signs onset more than 3 months after index arthroplasty.
- •3. 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)
- •4. Infection due to a tedizolid susceptible microorganism.
- •5. Surgical approach: one or two – stage exchange of all implant components.
- •6. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1.Patients with a prosthetic joint infection with negative cultures.
- •2. Patients who undergo debridement without removing the prosthesis or only partially removed
- •3. =15 days of other antibiotic treatment before starting tedizolid
- •4.Life expeancy = 1 year.
- •5.Previous enrollment in this protocol.
- •6.Hypersensitivity to tedizolid or any formulation excipients.
- •7.Concurrent use of another investigational medication within 30 days of study entry.
- •8.Women who are pregnant or breast-feeding
研究者
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Efficacy and Tolerance of 4 Weeks of Tedizolid in Prosthetic Joint Infections Treated With Implant RemovalProstheses InfectionNCT03746327Fundacion Clinic per a la Recerca Biomédica30
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