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Completed

NCT Number: NCT03081273

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre de reference des infections ostéo-articulaires- Hôpital de la Croix Rousse

Lyon, 69004, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • diabetic foot osteomyelitis
  • pressure ulcer-associated osteomyelitis

Treatment and study plan

Primary outcomes

  1. 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)

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 16, 2017
Registry last updated
Aug 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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