Clinical trial NCT03263832: Evaluation of the Antibiofilmogramme Test During Orthopaedic Device-Related Infection
Official title: Demonstration of Clinical Value of Antibiofilmogramme Test for Monomicrobial S. Aureus Orthopaedic Device-Related Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prosthetic Joint Infection
Staphylococcus Aureus
Biofilm
Keywords: Antibiogramme
Antibiofilmogramme
Lead sponsor: BioFilm Control
Sponsor class: INDUSTRY
Collaborators: name: Hospices Civils de Lyon
First posted: 2017-08-28
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population is composed of patient with a monomicrobial S. aureus orthopaedic device-related infections.

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

Eligibility criteria: 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

Primary outcomes:
measure: Success or treatment failure
timeFrame: From surgical intervention to one year after the end of antimicrobial therapy.
Secondary outcomes:
Other outcomes:
measure: Age
timeFrame: Baseline (Day 0)
measure: Sex
timeFrame: Baseline (Day 0)
measure: Body mass index
timeFrame: Baseline (Day 0)
measure: Charlson Comorbidity Index
timeFrame: Baseline (Day 0)
measure: Localization of the infection
timeFrame: Baseline (Day 0)
measure: Orthopaedic device
timeFrame: Baseline (Day 0)
measure: Time of onset of symptoms
timeFrame: Baseline (Day 0)
measure: Time of microbiological diagnostics
timeFrame: Baseline (Day 0)
measure: Time of implantation of the device
timeFrame: Baseline (Day 0)
measure: Microbiological analysis
timeFrame: Baseline (Day 0)
measure: Antibiogram results
timeFrame: Baseline (Day 0)
measure: Surgical Therapy
timeFrame: Baseline (Day 0)
measure: Antibiotics taken
timeFrame: through study completion, an average of 1 year
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: Frederic Laurent, PharmD - PhD
role: PRINCIPAL_INVESTIGATOR
References: