NCT03950063

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 15, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

June 15, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2021

Completed
Last Updated

May 15, 2019

Status Verified

May 1, 2019

Enrollment Period

1 year

First QC Date

May 13, 2019

Last Update Submit

May 13, 2019

Conditions

Prosthesis and Bone InfectionsCutibacterium Acnes

Keywords

Cutibacterium acnes ProsthesisBone Infections

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

Patients with Cutibacterium acnes bone infections

Patients with Cutibacterium acnes orthopedic material infections

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Cutibacterium acnes bone infections

You may qualify if:

  • bone infection with C. acnes,
  • isolation of the strain,
  • presence of a single species,
  • conservation of a viable strain,
  • patients over 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Damien JOLLY

Reims, France

Location

Central Study Contacts

Xavier OHL

CONTACT

03 26 78 32 72xohl@chu-reims.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2019

First Posted

May 15, 2019

Study Start

June 15, 2019

Primary Completion

June 15, 2020

Study Completion

June 15, 2021

Last Updated

May 15, 2019

Record last verified: 2019-05

Locations

FR(1)