Evaluation of the Antibiofilmogramme Test During Orthopaedic Device-Related Infection

• Conditions: Staphylococcus Aureus; Prosthetic Joint Infection; Biofilm

• Registration Number: NCT03263832
• Lead Sponsor: BioFilm Control

Brief Summary

This is an observational study that does not change routine care.

The primary objective of this study is to investigate the correlation between the administration of an antibiotherapy able to prevent biofilm formation according to the results of the Antibiofilmogramme test, and the relapse of the infection for patient with orthopaedic device-related infection.

Detailed Description

The secondary objectives are:

A. Investigate the role of antibiogram-antibiofilmogramme concordance (in terms of S. aureus strains and prescribed antibiotics) in orthopaedic device-related infection management.

B. Investigate the capacity of S. aureus isolates to form biofilm in presence/absence of antibiotics.

C. Create an S. aureus strain collection for future ancillary studies

Study Timeline

• Study Start: 2015-06-01
• Study First Submitted: 2017-08-23
• Study First Submitted QC: 2017-08-24
• Study First Posted: 2017-08-28
• Primary Completion: 2018-02-28
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-01
• Last Update Posted: 2021-03-02
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• The patient must have been informed and received a non-opposition consent form
• Patient with a monomicrobial S. aureus bone and joint infections
• Patient with prosthetic or orthopaedic device

Exclusion Criteria

• Bone and joint infection from pressure ulcer, vascular injury or diabetic foot ulcer
• Polymicrobial prosthetic joint infection
• The patient is participating in, or has participated in within the past 3 months, another interventional study, or is currently in an exclusion period determined by a preceding study
• Patient is under judicial protection, under tutorship or curatorship
• The patient expresses his opposition to participate to the study
• It is impossible to correctly inform the patient
• The patient is pregnant, parturient or breastfeeding
• Emergency situation precluding correct study implementation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Success or treatment failure	From surgical intervention to one year after the end of antimicrobial therapy.	Presence or absence of microbiological treatment failure confirmed by S. aureus positive clinical samples. The diagnostic of a S. aureus positive clinical sample indicated a treatment failure. Treatment success corresponded to an absence of clinical or microbiological treatment failure, or treatment failure with positive clinical sample other than S. aureus.

Trial Locations

Locations (1)

Hospices Civils de Lyon; 🇫🇷 Lyon, France