Corynebacterium InfectionsNCT03081273
Corynebacterium Spp Bone and Joint Infection: Retrospective Study of Microbiological, Diagnostic and Therapeutic Features
An observational study of Corynebacterium Infections, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corynebacterium Infections
- How many people
- 49 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2016to May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with microbiologically proven Corynebacterium bone and joint infection.
Who may be able to join
- Adult patients (i.e age ≥ 18-year-old) with microbiologically proven Corynebacterium bone and joint infection, with or without implant
Who cannot join
- diabetic foot osteomyelitis
- pressure ulcer-associated osteomyelitis
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de reference des infections ostéo-articulaires- Hôpital de la Croix Rousse
Lyon, 69004
About this study
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.
- Conditions
- Corynebacterium Infections
- Keywords
- Antimicrobial susceptibility, Biofilm formation, Bone and joint infection, Corynebacterium spp, Osteoblast, Outcome, Prosthetic joint infection
- Medical subject headings
- Corynebacterium Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of microbiological features of Corynebacterium infection
microbiological identification at species level will be confirmed for each isolate using routine mass spectrometry (MALDI-TOFF-MS)
Measured: at diagnosis
antimicrobial susceptibility
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
Measured: at diagnosis
Secondary outcomes (4)
ability of clinical isolate to form biofilm
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
Measured: at diagnosis
Corynebacterium isolate ability to invade and persist within bone cells
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
Measured: at diagnosis
Surgical management and antimicrobial therapy in patients with bone or joint infection
Surgical management and antimicrobial therapy will be described and compared to current guidelines
Measured: at the end of follow up
Treatment failure in patients with bone or joint infection
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.
Measured: one to two years after the end of antimicrobial therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2017
- Study startJun 2016
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corynebacterium InfectionsStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tristan Ferry, MD,PhD, Principal investigator, Centre de reference des infections ostéo-articulaires de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03081273
- Sponsor's protocol ID
- 69HCL16_0390
- Status last verified
- Aug 2017
- First submitted
- 9 Mar 2017
- Last updated
- 25 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corynebacterium Spp Bone and Joint Infection: Retrospective Study of Microbiological, Diagnostic and Therapeutic Features
- ClinicalTrials.gov ID
- NCT03081273
- Acronym / sponsor ID
- 69HCL16_0390
- Conditions
- Corynebacterium Infections
- Keywords
- Antimicrobial susceptibility, Biofilm formation, Bone and joint infection, Corynebacterium spp, Osteoblast, Outcome, Prosthetic joint infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 16 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with microbiologically proven Corynebacterium bone and joint infection.
Key inclusion criteria (1 listed)
- Adult patients (i.e age ≥ 18-year-old) with microbiologically proven Corynebacterium bone and joint infection, with or without implant
Key exclusion criteria (2 listed)
- diabetic foot osteomyelitis
- pressure ulcer-associated osteomyelitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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
4 secondary outcomes
ability of clinical isolate to form biofilm
Time frame: at diagnosis
Corynebacterium isolate ability to invade and persist within bone cells
Time frame: at diagnosis
Surgical management and antimicrobial therapy in patients with bone or joint infection
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2017.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tristan Ferry, MD,PhD principal investigator
Centre de reference des infections ostéo-articulaires de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Corynebacterium Infections, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of microbiological features of Corynebacterium infection (time frame: at diagnosis). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2017.