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

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ClinicalTrials.gov Identifier: NCT03850548
Recruitment Status : Completed
First Posted : February 22, 2019
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
Eugénie MABRUT, Hospices Civils de Lyon

Study Description
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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.

Condition or disease Intervention/treatment
Bone and Joint Infection Other: Prosthetic joint infection with Cutibacterium acnes

Study Design
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Study Type : Observational
Actual Enrollment : 6 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Chronic Infections on Articular Prostheses With C. Acnes Diagnosed by Specific PCR : Descriptive Study of 6 Patients
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : March 1, 2017
Actual Study Completion Date : February 1, 2018

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Groups and Cohorts
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Group/Cohort Intervention/treatment
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
patients having a prosthesis infection with C.acnes identified by specific PCR


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes 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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03850548


Locations
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France
Hospices Civils de Lyon
Lyon, France, 69004
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Study Director: Tristan Ferry, Md,PhD HCL
More Information
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Responsible Party: Eugénie MABRUT, clinical research assistant, Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03850548    
Other Study ID Numbers: 18-031
First Posted: February 22, 2019    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eugénie MABRUT, Hospices Civils de Lyon:
bone and joint infection
Propionibacterium acnes
Cutibacterium acnes
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Disease Attributes
Pathologic Processes