Cutibacterium Acnes in Bone and Joint Infections (CaBJI)

May 13, 2019 updated by: CHU de Reims
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.

Study Overview

Status

Unknown

Conditions

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

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Reims, France
        • Damien JOLLY

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Cutibacterium acnes bone infections

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Patients with Cutibacterium acnes bone infections
Patients with Cutibacterium acnes orthopedic material infections

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 0
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).
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Reims

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 15, 2019

Primary Completion (Anticipated)

June 15, 2020

Study Completion (Anticipated)

June 15, 2021

Study Registration Dates

First Submitted

May 13, 2019

First Submitted That Met QC Criteria

May 13, 2019

First Posted (Actual)

May 15, 2019

Study Record Updates

Last Update Posted (Actual)

May 15, 2019

Last Update Submitted That Met QC Criteria

May 13, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PA18027

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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