Susceptibility Testing of Biofilm to Guide Treatment of Periprosthetic Joint Infections

Summary

The overall purpose of this clinical treatment research project is to explore novel diagnostics that can guide the treatment of infections associated to orthopaedic implants, in order to improve patient outcomes and reduce the development of antibiotic resistance.

The project aims are:

(i) To improve the current diagnostic approaches and treatments of periprosthetic joint infections (PJI) (ii) To investigate the pathogenesis of PJI through the characterization of the virulence carried by the causative pathogens

This multidisciplinary project addresses implant-associated infection and its contribution to increasing antibiotic resistance. Both lead to longer hospital stays, higher medical costs and increased morbidity and mortality. Antibiotic resistance is globally considered as one of the greatest and most urgent risk in medicine. Implant-associated infections are commonly caused by biofilms. Biofilms can be described as 'a community of bacterial cells connected by their secreted extracellular matrix'. Since antibiotics are designed to fight planktonic free-living bacteria, studying antibiotic resistance in biofilm communities poses a paradigm shift. Furthermore, bacteria in biofilms are up to 1000 times more resistant to antibiotics than planktonic bacteria. Mechanisms involved in a biofilm infection also play a crucial role in the development of antibiotic resistance. Hospital-acquired infections are the fourth leading cause of disease and 70% are associated with medical implants and caused by staphylococcal biofilms. In addition, the level of antimicrobial resistance in bacteria causing implant-associated infections has increased worldwide, leaving patients with fewer treatment options.

In this study the investigators will randomize patients with PJI to either standard MIC susceptibility or MIC and MBEC susceptibility guided treatment with oral antibiotic combinations; (i) Non cell wall active standard of care antibiotic combination (MIC-guided) for 6 weeks.

(ii) Or; non cell wall active antibiotic combination according to a MBEC-based decision algorithm for 6 weeks.

In this pilot project, the primary endpoint is how often treatment changes with the MBEC susceptibility testing compared to only MIC-susceptibility testing.

Conditions

• Prosthetic Joint Infection
• Prosthetic Infection
• Hip Prosthesis Infection
• Knee Prosthesis Infection

Interventions

DIAGNOSTIC_TEST

MIC or MBEC+MIC based treatment algorithm

i) Non cell wall active standard of care antibiotic combination (MIC-guided) for 6 weeks. ii) Non cell wall active antibiotic combination according to a MBEC-based decision algorithm for 6 weeks.

Sponsors & Collaborators

• Göteborg University

  collaborator OTHER

• Vastra Gotaland Region

  lead OTHER_GOV

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-08-15

Primary Completion

2022-12-31

Completion

2023-12-31

Countries

• Sweden

Study Locations