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临床试验/NCT03850860
NCT03850860已完成不适用

Comparison of the Tolerance of Vancomycin in Combination With Piperacillin/Tazobactam or Cefepim as Empirical Antimicrobial Therapy of Prosthetic Joint Infection

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 178 人开始时间: 2018年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
178
试验地点
1
主要终点
Rate of Treatment Failure

研究概览

简要总结

The empirical use of vancomycin in combination with a broad-spectrum beta-lactam is currently recommended after the initial surgery of prosthetic joint infection (PJI). However, the tolerability of such high-dose intravenous regimens is poorly known. T

详细描述

The empirical use of vancomycin in combination with a broad-spectrum beta-lactam is currently recommended after the initial surgery of prosthetic joint infection (PJI). However, the tolerability of such high-dose intravenous regimens is poorly known. The empirical antimicrobial therapy of PJI is associated with an important rate of adverse, linked with the use of the vancomycin and the piperacillin-tazobactam combination. Some studies suggest to use vancomycin-cefepime, which remains to be evaluated in PJI.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients having had a prosthetic joint infection and having had a postoperative empirical antibiotherapy with combination of vancomycine and piperacillin-tazobactam or vancomycine and cefepime

排除标准

  • 未提供

结局指标

主要结局

Rate of Treatment Failure

时间窗: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption

Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin

次要结局

  • rate of bacteria responsible for infection(Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
  • rate of adverse events(Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eugénie MABRUT

clinical research assistant

Hospices Civils de Lyon

研究点 (1)

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