NCT03850548

Brief Summary

Osteaoarticular infection due to C. acnes are known to be of late onset, causing chronic infection possibly pauci-symptomatic. Osteaoarticular infection due to C. acnes represents a diagnostic challenge, since C. acnes is slow and difficult to grow, and can also be considered a contaminant.A 16S universal PCR bacteriological diagnosis has been proposed but is lacking of sensitivity. A specific C. acnes PCR was developed in 2010, but is not used routinely.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 22, 2019

Completed
Last Updated

February 22, 2019

Status Verified

February 1, 2019

Enrollment Period

1.2 years

First QC Date

February 20, 2019

Last Update Submit

February 20, 2019

Conditions

Bone and Joint Infection

Keywords

bone and joint infectionPropionibacterium acnesCutibacterium acnes

Outcome Measures

Primary Outcomes (1)

  • Rate of diagnostic delay

    time between surgery and detection of C. acnes by PCR

    Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption

Secondary Outcomes (3)

  • rate of radiologic signs

    Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption

  • rate of duration of antibiotherapy

    Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption

  • rate of use of this diagnostic

    Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption

Study Arms (1)

Prosthetic joint infection with Cutibacterium acnes

Chronic infections on articular prostheses with Cutibacterium acnes diagnosed by specific PCR

Other: Prosthetic joint infection with Cutibacterium acnes

Interventions

Prosthetic joint infection with Cutibacterium acnesOTHER

patients having a prosthesis infection with C.acnes identified by specific PCR

Prosthetic joint infection with Cutibacterium acnes

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients having had infection prothesis vith C. acnes identified by PCR and managed at the croix rousse hospital

You may qualify if:

  • patients having had infection prothesis vith C. acnes identified by PCR

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon

Lyon, 69004, France

Location

MeSH Terms

Interventions

chloropentaamminerhodium(III)

Study Officials

  • Tristan Ferry, Md,PhD

    HCL

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical research assistant

Study Record Dates

First Submitted

February 20, 2019

First Posted

February 22, 2019

Study Start

January 1, 2016

Primary Completion

March 1, 2017

Study Completion

February 1, 2018

Last Updated

February 22, 2019

Record last verified: 2019-02

Locations

FR(1)