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出境医 / 临床实验 / Cutibacterium Acnes in Bone and Joint Infections (CaBJI)

Cutibacterium Acnes in Bone and Joint Infections (CaBJI)

Study Description
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
Layout table for study information
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
Arms and Interventions
Group/Cohort
Patients with Cutibacterium acnes bone infections
Patients with Cutibacterium acnes orthopedic material infections
Outcome Measures
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

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

Locations
Layout table for location information
France
Damien JOLLY
Reims, France
Contact: Xavier OHL    03 26 78 32 72    xohl@chu-reims.fr   
Sponsors and Collaborators
CHU de Reims
Tracking Information
First Submitted Date May 13, 2019
First Posted Date May 15, 2019
Last Update Posted Date May 15, 2019
Estimated Study Start Date June 15, 2019
Estimated Primary Completion Date June 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 13, 2019)
  • 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.
  • 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).
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Cutibacterium Acnes in Bone and Joint Infections
Official Title Cutibacterium Acnes in Bone and Joint Infections
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.
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with Cutibacterium acnes bone infections
Condition
  • Prosthesis and Bone Infections
  • Cutibacterium Acnes
Intervention Not Provided
Study Groups/Cohorts Patients with Cutibacterium acnes bone infections
Patients with Cutibacterium acnes orthopedic material infections
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: May 13, 2019) 		50
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 15, 2021
Estimated Primary Completion Date June 15, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Xavier OHL 03 26 78 32 72 xohl@chu-reims.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03950063
Other Study ID Numbers PA18027
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party CHU de Reims
Study Sponsor CHU de Reims
Collaborators Not Provided
Investigators Not Provided
PRS Account CHU de Reims
Verification Date May 2019

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