Evaluation of the Antibiofilmogramme Test During Orthopaedic Device-Related Infection

NCT03263832 | Unknown

• 1 other identifier: 2015-A0022472
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Prosthetic Joint Infection; Staphylococcus Aureus; Biofilm

Keywords

Antibiogramme; Antibiofilmogramme

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Age

  Baseline (Day 0)

• Sex

  Baseline (Day 0)

• Body mass index

  Baseline (Day 0)

Study Arms (2)

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

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

Interventions

Antibiofilmogramme DIAGNOSTIC_TEST

An Antibiofilmogramme (BioFilm Control) evaluates the capacity of a series of antibiotics to inhibit the growth of bacterial biofilms for a given bacterial isolate.

Exposed; Not Exposed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Bone and joint infection from pressure ulcer, vascular injury or diabetic foot ulcer
• Polymicrobial prosthetic joint infection
• 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

Sponsors & Collaborators

• BioFilm Control: lead
• Hospices Civils de Lyon: collaborator

Study Sites (1)

Hospices Civils de Lyon

Lyon, 69004, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

The S. aureus strains isolated will be maintained in a collection for future ancillary studies.

MeSH Terms

Conditions

Staphylococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Frederic Laurent, PharmD - PhD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2017
• First Posted: August 28, 2017
• Study Start: June 1, 2015
• Primary Completion: February 28, 2018
• Study Completion: December 1, 2021
• Last Updated: March 2, 2021

Record last verified: 2021-03

Locations

FR (1)