Short Against Long Antibiotic Therapy for Infected Orthopedic Sites
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 495
- 试验地点
- 1
- 主要终点
- Clinical remission related to the duration of total, postdebridement, antibiotic use
研究概览
简要总结
The investigators will perform two concomitant RCTs, depending on the presence of infected osteosynthesis material at enrolment:
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SALATIO 1. Infected implant not removed (or new material inserted): Randomization 6 vs. 12 weeks (+/- 5 days) of total antibiotic therapy counted since the first debridement for infection. Early switch to oral targeted therapy.
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SALATIO 2. Infected implant without residual material (definitive removal or within the interval of a two-stage exchange): Randomization 3 vs. 6 weeks (+/- 5 days) of total antibiotic therapy counted since the first debridement for infection. Early switch to oral targeted therapy.
详细描述
The optimal duration of postoperative, systemic antibiotic therapy for implant-related orthopedic infections, with or without implant removal, is unknown.
Retrospective studies suggest that a maximum duration of 6 weeks is not inferior to longer administrations; even if the infected implants are kept in place or during a one-stage exchange. Prospective-randomized trials (RCT) suggest that even shorter durations, such 3 or 4 weeks, are possible, when the implant is removed. Likewise, in prospective studies, 6 or 8 weeks of systemic antibiotics are not inferior to the current 12 weeks during DAIR (debridement, antibiotic and implant retention), or during the one-stage exchange; except for one single RCT suggesting a better outcome for 12 weeks in the substrata of arthroplasty infections undergoing the DAIR procedure.
However, these RCTs concern selected branches of orthopedic surgery; especially prosthetic joint infections. The investigators intend to expand these evaluations to all fields of orthopedic and hand surgery. The only exceptions would be spine surgery, for which a multicenter, separate RCT is already under way (SASI-trials). The second exception would be the treatment of implant-free diabetic foot infections, for which two RCTs are underway.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years on admission
- •Orthopedic bone and implant infections including musculoskeletal grafts
- •Intraoperative debridement with any surgical technique
- •12 months of scheduled follow-up from hospitalization
- •Bacterial orthopedic infections of any nature
- •First or second episode of infection
排除标准
- •Mycobacterial, fungal, nocardial, and Actinomyces infections
- •Purely soft tissue infections
- •Non-resected cancer in the infection site
- •Purely intrasynovial infections (native joint septic arthritis)
- •More than three debridements performed for infection
- •Absence of at least one surgical intraoperative debridement
- •Spine infections (investigated in another trial)10
- •Diabetic foot infections (investigated in another trial)7
- •Documented endocarditis according to the Duke criteria
- •At least 2 prior infection episodes at the actual infection site
研究组 & 干预措施
Long Antibiotic Arm
Without implant material in place:
6 weeks of systemic post-surgical antibiotic therapy
With mateial in place 12 weeks of systemic post-surgical antibiotic therapy
干预措施: Antibiotic (Drug)
Short Antibiotic Arm
Without implant material in place:
3 weeks of systemic post-surgical antibiotic therapy
With mateial in place 6 weeks of systemic post-surgical antibiotic therapy
干预措施: Antibiotic (Drug)
结局指标
主要结局
Clinical remission related to the duration of total, postdebridement, antibiotic use
时间窗: 6 weeks postoperatively, or 1 year postoperatively in case of implant-related orthopedic surgery
Clinical assessment during routine surgical controls. Definition of clinical failure accoding to to sandard criteria in the literature (surgical revision, pain, local inflammation, discharge, several deep intraoperative bacterial tissue samples)
Microbiological recurrence in relation to the total, postdebridement, antibiotic use
时间窗: 6 weeks postoperatively, or 1 year postoperatively in case of implant-related orthopedic surgery
Recurrence of infection, with the same pathogens, after completing the antibiotic treatment for the index infection
次要结局
- Description of all clinical failures of any sort(6 weeks postoperatively, or 1 year postoperatively in case of implant-related orthopedic surgery)
- Adverse events in each study arm, and in relation to the antibiotics used(6 weeks postoperatively, or 1 year postoperatively in case of implant-related orthopedic surgery)
- Length of hospital stay in acute care surgery (without rehabilitation)(6 weeks postoperatively, or 1 year postoperatively in case of implant-related orthopedic surgery)