ACTRN12617000127303已完成4 期
Pilot trial evaluating the efficacy of different antibiotic treatments for the treatment of prosthetic joint infection in adults who have undergone joint replacement surgery.
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 o limit(—)
- 性别
- All
入选标准
- •1) Aged >=18 years
- •2) Prosthetic joint infection of the hip or knee (according to IDSA diagnostic criteria)
- •3) Acute infection (either a. Diagnosis <4 weeks from date of implantation of prosthesis OR b. Suspected acute haematogenous infection with <3 weeks from symptom onset to diagnosis)
- •4) Meet IDSA criteria for DAIR (stable implant, no sinus, absence of septic shock).
- •5) One or more identified causative organisms (can be Gram positive, Gram negative or mixed)
- •6) Adequate debridement has been performed or is planned (this means an open as opposed to arthroscopic debridement and exchange of modular components)
- •7) Initial diagnosis is <21 days prior to randomisation.
排除标准
- •1) Additional diagnosis requiring >2 weeks of IV antibiotics in the opinion of the site PI (e.g. Staphylococcus aureus bacteraemia).
- •2) Patient not treated with curative intent.
- •3) Patient unlikely to survive for > 12 months (in the opinion of the site PI).
- •4) Gram positive rifampicin resistant causative organism.
- •5) Gram negative ciprofloxacin resistant causative organism.
- •6) At least one causative organism is Proprionibacterium spp., Gram negative anaerobes, Fungi, Mycobacteria.
研究者
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