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临床试验/NCT03081273
NCT03081273已完成不适用

Corynebacterium Spp Bone and Joint Infection: Retrospective Study of Microbiological, Diagnostic and Therapeutic Features

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2016年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
49
试验地点
1
主要终点
Description of microbiological features of Corynebacterium infection

研究概览

简要总结

Corynebacterium spp have been considered as innocuous commensals of human skin, but are now accepted as important opportunistic pathogens responsible for various nosocomial infections, especially implicating foreign materials. In particular, they accounted for up to 10% of prosthetic joint infection (PJI), and are mostly identified in chronic forms of bone and joint infections (BJI). However, little is known about the pathophysiological pathway implicated in Corynebacterium BJI, species distribution and antimicrobial susceptibility, and the management of these difficult-to-treat clinical entities.

This study aims to report a retrospective cohort of patients with Corynebacterium spp BJI, aiming to : i) describe microbiological characteristics of the implicated clinical isolates, including species identification and antimicrobial susceptibility (and especially according to previous antimicrobial exposure); ii) assess pathophysiological mechanisms associated with BJI chronicity, including biofilm formation and bone cell invasion, to better understand mechanisms of Corynebacterium spp and to evaluate their ability to distinguished colonizing and infective isolates; iii) describe the medical (nature and duration of antimicrobial therapy) and surgical management of these patients; and iv) evaluate the patient outcome according to this management strategy, and highlight risk factor for treatment failure in order to improve patient's management.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

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

入选标准

  • Adult patients (i.e age ≥ 18-year-old) with microbiologically proven Corynebacterium bone and joint infection, with or without implant

排除标准

  • diabetic foot osteomyelitis
  • pressure ulcer-associated osteomyelitis

结局指标

主要结局

Description of microbiological features of Corynebacterium infection

时间窗: at diagnosis

microbiological identification at species level will be confirmed for each isolate using routine mass spectrometry (MALDI-TOFF-MS)

antimicrobial susceptibility

时间窗: at diagnosis

antimicrobial susceptibility testing performed according to current guidelines of the French committee for antimicrobial susceptibility testing. Antimicrobial susceptibility profile will be interpreted according to previous exposition to antimicrobials, including new molecules such as daptomycin

次要结局

  • Surgical management and antimicrobial therapy in patients with bone or joint infection(at the end of follow up)
  • ability of clinical isolate to form biofilm(at diagnosis)
  • Corynebacterium isolate ability to invade and persist within bone cells(at diagnosis)
  • Treatment failure in patients with bone or joint infection(one to two years after the end of antimicrobial therapy)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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