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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04488458
Other study ID # 2020-01471
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 15, 2021
Est. completion date December 31, 2023

Study information

Verified date July 2021
Source Vastra Gotaland Region
Contact Ola Rolfson, Professor
Phone +46 313430852
Email ola.rolfson@vgregion.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Intervention

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.

Locations

Country Name City State
Sweden Ortopedi, Sahlgrenska University Hospital Mölndal

Sponsors (2)

Lead Sponsor Collaborator
Vastra Gotaland Region Göteborg University

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Zaborowska M, Tillander J, Brånemark R, Hagberg L, Thomsen P, Trobos M. Biofilm formation and antimicrobial susceptibility of staphylococci and enterococci from osteomyelitis associated with percutaneous orthopaedic implants. J Biomed Mater Res B Appl Biomater. 2017 Nov;105(8):2630-2640. doi: 10.1002/jbm.b.33803. Epub 2016 Oct 25. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Correlation between the virulence properties of the causative bacteria and patient outcome (infection resolution versus recurrent infection) The staphylococcal strains isolated from the patients with PJI will be characterised by phenotypic tests and whole genome sequencing to determine their virulence properties and carriage of genes involved in biofilm formation, antimicrobial resistance and production of toxins. Then the particular virulence of the strains will be correlated to the patients outcome, to be able to assess if more virulence carriage correlates to worse outcome (recurrent infection) 36 months
Primary Number of changes in antimicrobial regimen other than standard of care Proportions of antimicrobial regimens other than standard of care through application of proposed MBEC-algorithm. 6 weeks
Secondary Repeat procedure, relapse or reinfection Number of repeat procedures, relapses or reinfections, according to MSIS-criteria of PJI 12 months
Secondary Oxford Hip Score Hip specific patient-reported outcome measure 12 months
Secondary EQ-5D Generic health status patient-reported outcome measure 12 months
Secondary Time to revision A shorter time could potentially indicate that the right decision is taken at an earlier stage 12 months
Secondary Inpatient care Resource consumption measure (days). Up to 12 months
Secondary Outpatient visits Resource consumption measure, number of visits, type of visits. Up to 12 months
Secondary Discharge destination Resource consumption measure. The type of facility a patient is discharged to (rehab facility, nursing home, home, home care). Up to 12 months
Secondary Heath care costs Compound measure using data from outcome 6-8 (currency EUR). Up to 12 months
Secondary Development of additional antimicrobial resistance of the relapse causative strain At relapse surgery, the causative strain will be isolated by new biopsy cultures. Then the susceptibility of the causative strain will be tested again to evaluate any possible emergence of resistance against the antimicrobials previously used in the study. This will confirm if the given antimicrobial treatment has lead to antimicrobial resistance in a potential relapse strain isolated at a later occasion. 12 months
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