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

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ClinicalTrials.gov Identifier: NCT03081273
Recruitment Status : Completed
First Posted : March 16, 2017
Last Update Posted : August 25, 2017
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.


Condition or disease
Corynebacterium Infections

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Study Type : Observational
Actual Enrollment : 49 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Corynebacterium Spp Bone and Joint Infection: Retrospective Study of Microbiological, Diagnostic and Therapeutic Features
Actual Study Start Date : June 2016
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

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Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with microbiologically proven Corynebacterium bone and joint infection.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03081273


Locations
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France
Centre de reference des infections ostéo-articulaires- Hôpital de la Croix Rousse
Lyon, France, 69004
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Tristan Ferry, MD,PhD Centre de reference des infections ostéo-articulaires de Lyon

Additional Information:
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03081273     History of Changes
Other Study ID Numbers: 69HCL16_0390
First Posted: March 16, 2017    Key Record Dates
Last Update Posted: August 25, 2017
Last Verified: August 2017

Keywords provided by Hospices Civils de Lyon:
Antimicrobial susceptibility
Biofilm formation
Bone and joint infection
Corynebacterium spp
Osteoblast
Outcome
Prosthetic joint infection

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Arthritis, Infectious
Corynebacterium Infections
Arthritis
Joint Diseases
Musculoskeletal Diseases
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections