- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03850548
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
Status
Completed
Conditions
Intervention / Treatment
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
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-
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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-031
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.