Evaluation of the Antibiofilmogramme Test During Orthopaedic Device-Related Infection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-01

Study Completion Date

2021-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Biofilm Formation in Staphylococcus Epidermidis Associated Implant Infections

NCT02640937

Staphylococcal Infections

COMPLETED

Antibiogram and Biofilm Formation of Bacteria Causing Prosthetic Joint Infections Isolated From Assiut University Hospital

NCT05239312

Prosthetic Joint Infection

UNKNOWN

Evaluation of the Antibiofilmogramme® Test During Diabetic Foot Infections

NCT02378493

Diabetic Foot Staphylococcus Aureus

COMPLETED NA

Bacterial Phenotype of Staphylococcus Aureus Has no Effect on Patients' Clinical Outcome in Orthopedic Device Related Bone Infections

NCT02971657

Staphylococcal Infections

COMPLETED

Clinical Relevance of Intracellular Staphylococci in BOne and Joint Infections

NCT04625478

Staphylococcus Bone and Joint Infection

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prosthetic Joint Infection Staphylococcus Aureus Biofilm

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Antibiofilmogramme

Intervention Type 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.

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.

Antibiofilmogramme

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No