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Cutibacterium Acnes in Bone and Joint Infections (CaBJI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03950063
Recruitment Status : Unknown
Verified May 2019 by CHU de Reims.
Recruitment status was:  Not yet recruiting
First Posted : May 15, 2019
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

Study Description
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Brief Summary:
Prosthetic Joint Infections (PJIs) are increasing with the use of orthopedic devices on an ageing population. Cutibacterium acnes is a commensal organism that plays an important role in the ecosystem healthy human skin, yet this species is also recognized as a pathogen in foreign body infection: endocarditis, prostatitis and specifically in PJIs. C. acnes is able to escape the immune system. This phenomenon could reflect two bacterial behavior: the bacterial internalization by host cells and the biofilm formation.

Condition or disease
Prosthesis and Bone Infections Cutibacterium Acnes

Detailed Description:
The aim of the study is to evaluate specific pathogenicity factors (ability to internalize bone cells and ability to form a biofilm) of bacteria derived from clinical strains of C. acnes isolated from bone infections on orthopedic material.
Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Cutibacterium Acnes in Bone and Joint Infections
Estimated Study Start Date : June 15, 2019
Estimated Primary Completion Date : June 15, 2020
Estimated Study Completion Date : June 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Groups and Cohorts
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Group/Cohort
Patients with Cutibacterium acnes bone infections
Patients with Cutibacterium acnes orthopedic material infections


Outcome Measures
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Primary Outcome Measures :
  1. Internalization capacity of C. acnes strains [ Time Frame: Day 0 ]
    C. acnes strains will be cultured for 5 days in rich medium at 37°C in anaerobic conditions. Then, the bacteria will be co cultured with bone cells (osteoblast) and bacteria will be internalized by the bone cells. After killing bacteria stayed outside of the cells with an antibiotic and lysis of the cells, the number of bacteria internalized will be counted on agar plate.

  2. Biofilm capacity of C. acnes strains [ Time Frame: Day 0 ]
    C. acnes strains will be cultured for 5 days in rich medium at 37°C in anaerobic conditions. Then, the biofilm biomass will be evaluated by Crystal violet staining. The amount of biofilm will be evaluated by absorbance (optic density by spectrophotometry).


Eligibility Criteria
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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 Cutibacterium acnes bone infections
Criteria

Inclusion Criteria:

  • bone infection with C. acnes,
  • isolation of the strain,
  • presence of a single species,
  • conservation of a viable strain,
  • patients over 18 years
Contacts and Locations
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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): NCT03950063


Contacts
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Contact: Xavier OHL 03 26 78 32 72 xohl@chu-reims.fr

Locations
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France
Damien JOLLY
Reims, France
Contact: Xavier OHL    03 26 78 32 72    xohl@chu-reims.fr   
Sponsors and Collaborators
CHU de Reims
More Information
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Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT03950063    
Other Study ID Numbers: PA18027
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CHU de Reims:
Cutibacterium acnes Prosthesis
Bone Infections
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Disease Attributes
Pathologic Processes