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Evaluation of the clinical implementation of biofilm susceptibility to antibiotics using Minimum Biofilm Eradication Concentration (MBEC) in addition to Minimum Inhibitory Concentration (MIC) to guide the treatment of periprosthetic joint infections; a prospective randomized clinical trial

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518350-17-00
Enrollment
64
Registered
2024-10-23
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periprosthetic hip joint infection Periprosthetic knee joint infection

Brief summary

Proportions of antimicrobial regimens other than 1st-line treatment that will be administered after the guidance of MIC-testing versus MIC- and MBEC-testing combined. [6 weeks]

Detailed description

Repeat procedure, relapse or reinfection [12 months], Oxford Hip Score/Oxford Knee Score [12 months], EQ-5D: Generic health status patient-reported outcome measure [12 months], Time to revision [12 months], Inpatient care: Resource consumption measure (days) [Up to 12 months], Outpatient visits: Resource consumption measure, number of visits, type of visits [Up to 12 months], Discharge destination: Resource consumption measure [Up to 12 months], Heath care costs: Compound measure using data from outcome 6-8 (currency EUR) [Time Frame: Up to 12 months], Development of additional antimicrobial resistance of the relapse causative strain [12 months], Correlation between the virulence properties of the causative bacteria and patient outcome (infection resolution versus recurrent infection) [12 months]

Interventions

DRUGLINEZOLID
DRUGRIFAMPICIN
DRUGLEVOFLOXACIN
DRUGCLINDAMYCIN

Sponsors

Vaestra Goetalandsregionen
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Proportions of antimicrobial regimens other than 1st-line treatment that will be administered after the guidance of MIC-testing versus MIC- and MBEC-testing combined. [6 weeks]

Secondary

MeasureTime frame
Repeat procedure, relapse or reinfection [12 months], Oxford Hip Score/Oxford Knee Score [12 months], EQ-5D: Generic health status patient-reported outcome measure [12 months], Time to revision [12 months], Inpatient care: Resource consumption measure (days) [Up to 12 months], Outpatient visits: Resource consumption measure, number of visits, type of visits [Up to 12 months], Discharge destination: Resource consumption measure [Up to 12 months], Heath care costs: Compound measure using data from outcome 6-8 (currency EUR) [Time Frame: Up to 12 months], Development of additional antimicrobial resistance of the relapse causative strain [12 months], Correlation between the virulence properties of the causative bacteria and patient outcome (infection resolution versus recurrent infection) [12 months]

Countries

Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026