Cutibacterium Acnes in Bone and Joint Infections

Cutibacterium Acnes Clinical Trial

— CaBJI  

Official title:

Cutibacterium Acnes in Bone and Joint Infections

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03950063
• Other study ID #: PA18027
• Status: Not yet recruiting
• Start date: June 15, 2019
• Est. completion date: June 15, 2021

Study information

• Verified date: May 2019
• Source: CHU de Reims
• Contact: Xavier OHL
• Phone: 03 26 78 32 72
• Email: xohl[@]chu-reims.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 15, 2021
• Est. primary completion date: June 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Cutibacterium Acnes
• Infection
• Prosthesis and Bone Infections

Locations

Country	Name	City	State
France	Damien JOLLY	Reims

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Internalization capacity of C. acnes strains	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.	Day 0
Primary	Biofilm capacity of C. acnes strains	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).	Day 0