Short vs. Long Antibiotic Treatment of Implant-free Osteoarticular Infections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Remission of infection
研究概览
简要总结
The investigators tested the working hypothesis if 4 weeks of systemic antibiotic treatment in implant-related orthopaedic infections is non-inferior to 6 weeks after complete removal of the infected implant. Randomization 1:1.
The study is completed. It halted prematurely and will not resume; participants are no longer being examined or receiving intervention.
详细描述
Former description of the study (now completed)
Osteoarticular infections related to orthopaedic implants are associated with substantial morbidity, prolongation of hospital stay, and additional costs. Due to the increasing number of patients with orthopaedic implants in Switzerland, similar to the rest of Europe and elsewhere, the number of infections is expected to increase. While the surgical treatment of these infections has been well studied, the ideal duration of antibiotic therapy after removal (explantation) of the infected implant remains unknown. For almost 40 years, the recommended total duration of post-explantation antibiotic therapy has been 6 weeks. This recommendation is based on expert's personal experience rather than on prospective randomized studies. Shorter treatment would decrease antibiotic-related adverse events and costs hospital stay for patients awaiting an eventual reinsertion of a new implant. If physicians and surgeon prescribe antibiotics for 6 weeks, this duration should be at least supported by evidence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥17 years old)
- •Total removal of the implant
排除标准
- •Primary native joint septic arthritis;
- •Co-trimoxazole prophylaxis because of immunosuppression;
- •Left-side endocarditis;
- •Persistent implant material in the infected area.
- •Infections with tuberculosis; mycobacteria; fungi; brucellosis; borreliosis; nocardiosis; and mycoplasmal osteosynthesis infections
研究组 & 干预措施
4 weeks of treatment
干预措施: Removal of infected implant (Procedure)
4 weeks of treatment
干预措施: Antibiotic durations (Drug)
6 weeks of treatment
干预措施: Removal of infected implant (Procedure)
6 weeks of treatment
干预措施: Antibiotic durations (Drug)
结局指标
主要结局
Remission of infection
时间窗: 12 months
Clinical evaluation
Adverse events
时间窗: 12 months
Clinical adverse events
次要结局
未报告次要终点
研究者
Ilker Uckay
Attending, Docent Dr. med. Ilker Uçkay
University Hospital, Geneva