- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Lyon, France, 69004
- Centre de reference des infections ostéo-articulaires- Hôpital de la Croix Rousse
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
at diagnosis
|
|
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
|
at diagnosis
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
at diagnosis
|
|
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
|
at diagnosis
|
|
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
|
at the end of follow up
|
|
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.
|
one to two years after the end of antimicrobial therapy
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tristan Ferry, MD,PhD, Centre de reference des infections ostéo-articulaires de Lyon
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL16_0390
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Corynebacterium Infections
-
Centre Hospitalier Intercommunal de Toulon La Seyne...Centre d'Epidémiologie et de Santé Publique des ArméesCompletedCorynebacterium Diphtheriae InfectionFrance
-
GlaxoSmithKlineNot yet recruitingDiphtheria-Tetanus-acellular Pertussis Vaccines
-
MassBiologicsCompleted
-
PT Bio FarmaCompleted
-
Sanofi Pasteur, a Sanofi CompanyCompletedMeningitis | MeningococcemiaUnited Kingdom
-
GlaxoSmithKlineCompleted
-
Chiang Mai UniversityThailand Center of Excellence for Life SciencesNot yet recruitingPertussis | Tetanus | Diphtheria | Vaccine-Preventable DiseasesThailand
-
Bornova No. 25 Mevlana Family Health CenterCompleted
-
Hasan Kalyoncu UniversityCompleted
-
Sanofi Pasteur, a Sanofi CompanyCompletedMeningitis | MeningococcemiaUnited States