Evaluation of the Antibiofilmogramme Test During Orthopaedic Device-Related Infection

Staphylococcus Aureus Clinical Trial

— BJIBiofilm  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03263832
• Other study ID #: 2015-A0022472
• Status: Active, not recruiting
• Start date: June 1, 2015
• Est. completion date: December 1, 2021

Study information

• Verified date: March 2021
• Source: BioFilm Control
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: December 1, 2021
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biofilm
• Communicable Diseases
• Infection
• Prosthesis-Related Infections
• Prosthetic Joint Infection
• Staphylococcus Aureus

Intervention

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.

Locations

Country	Name	City	State
France	Hospices Civils de Lyon	Lyon

Sponsors (2)

Lead Sponsor	Collaborator
BioFilm Control	Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

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