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

Bone and Joint Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03850548
• Other study ID #: 18-031
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: February 1, 2018

Study information

• Verified date: February 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: February 1, 2018
• Est. primary completion date: March 1, 2017
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Related Conditions & MeSH terms

• Bone and Joint Infection
• Communicable Diseases
• Infection

Intervention

Other:
• Prosthetic joint infection with Cutibacterium acnes
patients having a prosthesis infection with C.acnes identified by specific PCR

Locations

Country	Name	City	State
France	Hospices Civils de Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	rate of radiologic signs	prosthesis loosening or not	Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
Secondary	rate of duration of antibiotherapy	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
Secondary	rate of use of this diagnostic	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