Evaluation of the Antibiofilmogramme Test During Orthopaedic Device-Related Infection (BJIBiofilm)

Demonstration of Clinical Value of Antibiofilmogramme Test for Monomicrobial S. Aureus Orthopaedic Device-Related Infection

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Staphylococcus Aureus; Prosthetic Joint Infection; Biofilm
• Intervention / Treatment: Diagnostic test: Antibiofilmogramme

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 Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69004
    • Hospices Civils de Lyon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study population is composed of patient with a monomicrobial S. aureus orthopaedic device-related infections.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Exposed; Patients with a monomicrobial S. aureus orhtopaedic device-related infection who have received antibiotherapy able to prevent biofilm formation following surgical intervention (from day 0 to day 7). Upon inclusion, antibiograms were performed on the S. aureus isolated as part of routine procedure. S. aureus isolates was further analysed via an Antibiofilmogramme, which is an experimental element added by this research.	Diagnostic test: Antibiofilmogramme; An Antibiofilmogramme (BioFilm Control) evaluates the capacity of a series of antibiotics to inhibit the growth of bacterial biofilms for a given bacterial isolate.
Not Exposed; Patients with a monomicrobial S. aureus orhtopaedic device-related infection who not have received antibiotherapy able to prevent biofilm formation following surgical intervention (from day 0 to day 7). Upon inclusion, antibiograms were performed on the S. aureus isolated as part of routine procedure. S. aureus isolates was further analysed via an Antibiofilmogramme, which is an experimental element added by this research.	Diagnostic test: Antibiofilmogramme; An Antibiofilmogramme (BioFilm Control) evaluates the capacity of a series of antibiotics to inhibit the growth of bacterial biofilms for a given bacterial isolate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success or treatment failure	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.	From surgical intervention to one year after the end of antimicrobial therapy.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	(years)	Baseline (Day 0)
Sex	(m/f)	Baseline (Day 0)
Body mass index	(kg/m²)	Baseline (Day 0)
Charlson Comorbidity Index	(0-37)	Baseline (Day 0)
Localization of the infection	Knee, Hip or other	Baseline (Day 0)
Orthopaedic device	Prothesis, screw, plate or other	Baseline (Day 0)
Time of onset of symptoms	(date)	Baseline (Day 0)
Time of microbiological diagnostics	(date)	Baseline (Day 0)
Time of implantation of the device	(date)	Baseline (Day 0)
Microbiological analysis	Number of positive S. aureus biopsy samples	Baseline (Day 0)
Antibiogram results	Qualitative results per antibiotic type and dose: classification as sensitive, intermediate, resistance and MIC estimation by the Vitek	Baseline (Day 0)
Surgical Therapy	Conservative treatment (arthrotomy, debriedment, synovectomy) or removal of implant (one stage, two stage)	Baseline (Day 0)
Antibiotics taken	Name of the molecule, dose and duration	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: BioFilm Control
• Collaborators: Hospices Civils de Lyon
• Investigators: Principal Investigator: Frederic Laurent, PharmD - PhD, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2015
• Primary Completion (ACTUAL): February 28, 2018
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: August 23, 2017
• First Submitted That Met QC Criteria: August 24, 2017
• First Posted (ACTUAL): August 28, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 2, 2021
• Last Update Submitted That Met QC Criteria: March 1, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Antibiogramme; Antibiofilmogramme
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Disease Attributes; Infections; Communicable Diseases; Prosthesis-Related Infections
• Other Study ID Numbers: 2015-A0022472

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No