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临床试验/ACTRN12617000127303
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.

John Hunter Hospital0 个研究点目标入组 60 人开始时间: 2017年1月24日最近更新:
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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