Chronic Infections on Articular Prostheses With C. Acnes Diagnosed by Specific PCR

February 20, 2019 updated by: Eugénie MABRUT, Hospices Civils de Lyon

Chronic Infections on Articular Prostheses With C. Acnes Diagnosed by Specific PCR : Descriptive Study of 6 Patients

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.

Study Overview

Study Type

Observational

Enrollment (Actual)

6

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

      • Lyon, France, 69004
        • Hospices Civils de Lyon

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 to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • none

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: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Prosthetic joint infection with Cutibacterium acnes
Chronic infections on articular prostheses with Cutibacterium acnes diagnosed by specific PCR
patients having a prosthesis infection with C.acnes identified by specific PCR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of diagnostic delay
Time Frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of radiologic signs
Time Frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
prosthesis loosening or not
Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
rate of duration of antibiotherapy
Time Frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
measures of duration of the 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
Time Frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
descriptions of patients managed with this diagnostic
Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption

Collaborators and Investigators

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

Investigators

  • Study Director: Tristan Ferry, Md,PhD, HCL

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 (Actual)

January 1, 2016

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

February 20, 2019

First Submitted That Met QC Criteria

February 20, 2019

First Posted (Actual)

February 22, 2019

Study Record Updates

Last Update Posted (Actual)

February 22, 2019

Last Update Submitted That Met QC Criteria

February 20, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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