跳至主要内容
临床试验/EUCTR2005-005494-29-NO
EUCTR2005-005494-29-NO进行中(未招募)不适用

Rifampin combination therapy versus monotherapy in early staphylococcal infections after total hip and knee arthroplasty

llevål University Hospital0 个研究点目标入组 200 人开始时间: 2006年1月25日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
200

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

性别
All

入选标准

  • We will include patients with the diagnosis of prosthetic joint infections category 2 or 3 after total hip or knee replacement. Patients with clinical signs of infection (persisting local pain, erythema, warmth, wound healing disturbance, effusion and fever) with or without raised CRP, are scheduled for soft tissue revision. Diagnosis of staphylococci must be established by arthrocentesis or at surgical revision, and stapylococci must grow in at least 2/8 cultures. The infection must be diagnosed within 4 weeks of index operation or presumed debut of a hematogenous infection. The prosthesis must be stable and left in place after soft tissue revision. We will include patients from 10 different hospitals in Norway, and written informed consent will be required for all the study patients.
  • 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
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Exclusions criteria will be: Infection with microorganisms other than staphylococci, less than 2 years of expected survival, predictable inability to comply with the treatment and/or follow-up, contraindications to the use of rifampin, cloxacillin or vancomycin, acute or chronic liver disease, lack of written consent, fertile women, patients taking less than 80% of the study medication, and antimicrobial therapy during the last 2 weeks before surgical revision.

研究者

发起方
llevål University Hospital

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