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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

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

Brief Summary:

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.

Detailed Summary:
Sponsor: Hospices Civils de Lyon

Current Primary Outcome:

• Description of microbiological features of Corynebacterium infection [ Time Frame: at diagnosis ]
  microbiological identification at species level will be confirmed for each isolate using routine mass spectrometry (MALDI-TOFF-MS)
• antimicrobial susceptibility [ Time Frame: 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

Original Primary Outcome: Same as current

Current Secondary Outcome:

• ability of clinical isolate to form biofilm [ Time Frame: at diagnosis ]
  The ability of clinical isolate to form biofilm will be assessed using the classic photometric method based on crystal violet staining, and the BiofilmRingTest dynamic method evaluating the kinetic of biofilm formation based on magnetic beads immobilization when embedded in biofilm
• Corynebacterium isolate ability to invade and persist within bone cells [ Time Frame: at diagnosis ]
  Corynebacterium isolate ability to invade and persist within bone cells will be adressed using an in vitro model of human osteoblastic cells infection, developed in our laboratory, as previously described
• Surgical management and antimicrobial therapy in patients with bone or joint infection [ Time Frame: at the end of follow up ]
  Surgical management and antimicrobial therapy will be described and compared to current guidelines
• Treatment failure in patients with bone or joint infection [ Time Frame: one to two years after the end of antimicrobial therapy ]
  Treatment failure will include i) clinical and/or microbiological relapse after treatment disruption; ii) the need of additional surgery for septic reason; and iii) death related to the BJI or its management.

Original Secondary Outcome: Same as current

Information By: Hospices Civils de Lyon

Dates:
Date Received: March 9, 2017
Date Started: June 2016
Date Completion: June 2017
Last Updated: March 9, 2017
Last Verified: March 2017