FUSIDIC ACID for Periprosthetic joint infection (hip) | Periprosthetic joint infection (knee)

Inclusion criteria

• {"criterion_text":"- First-time PJI in hip or knee according to Musculoskeletal Infection Society (MSIS) definitions"}
• {"criterion_text":"- First DAIR (debridement, antibiotics and implant retention)"}
• {"criterion_text":"- Mono-microbial staphylococcal infection"}
• {"criterion_text":"- 14 days of intravenous treatment with either cloxacillin or vancomycin"}
• {"criterion_text":"- Standardized administration of local antibiotics."}

Exclusion criteria

• {"criterion_text":"- Allergy/previous toxic event/unacceptable drug interaction to most effective antibiotic combination according to either MIC or MBEC"}
• {"criterion_text":"- Severe drug interactions to MBEC-guided compound."}
• {"criterion_text":"- Pregnancy and women of childbearing potential (WOCBP)."}

Primary endpoints

• {"endpoint_text":"- 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]","definition_or_measurement_approach":"Measured as the proportion of antimicrobial regimens other than 1st-line treatment administered after guidance; time frame: 6 weeks (as stated)."}

Secondary endpoints

• {"endpoint_text":"- Repeat procedure, relapse or reinfection [12 months]","definition_or_measurement_approach":"Time frame: 12 months (as stated)."}
• {"endpoint_text":"- Oxford Hip Score/Oxford Knee Score [12 months]","definition_or_measurement_approach":"Patient-reported joint-specific functional scores; time frame: 12 months (as stated)."}
• {"endpoint_text":"- EQ-5D: Generic health status patient-reported outcome measure [12 months]","definition_or_measurement_approach":"EQ-5D patient-reported outcome; time frame: 12 months (as stated)."}
• {"endpoint_text":"- Time to revision [12 months]","definition_or_measurement_approach":"Time to surgical revision; time frame: 12 months (as stated)."}
• {"endpoint_text":"- Inpatient care: Resource consumption measure (days) [Up to 12 months]","definition_or_measurement_approach":"Resource consumption measured as inpatient days; time frame: up to 12 months (as stated)."}
• {"endpoint_text":"- Outpatient visits: Resource consumption measure, number of visits, type of visits [Up to 12 months]","definition_or_measurement_approach":"Resource consumption measured as number and type of outpatient visits; time frame: up to 12 months (as stated)."}
• {"endpoint_text":"- Discharge destination: Resource consumption measure [Up to 12 months]","definition_or_measurement_approach":"Discharge destination recorded as resource consumption measure; time frame: up to 12 months (as stated)."}
• {"endpoint_text":"- Heath care costs: Compound measure using data from outcome 6-8 (currency EUR) [Time Frame: Up to 12 months]","definition_or_measurement_approach":"Compound health care cost measure based on outcomes 6-8; time frame: up to 12 months (as stated)."}
• {"endpoint_text":"- Development of additional antimicrobial resistance of the relapse causative strain [12 months]","definition_or_measurement_approach":"Assessment of antimicrobial resistance development in relapse strains; time frame: 12 months (as stated)."}
• {"endpoint_text":"- Correlation between the virulence properties of the causative bacteria and patient outcome (infection resolution versus recurrent infection) [12 months]","definition_or_measurement_approach":"Correlation analysis between bacterial virulence properties and patient outcomes; time frame: 12 months (as stated)."}

Sweden

Earliest CTIS Part Ii Submission Date

23-09-2024

Latest Decision Or Authorization Date

23-10-2024

Processing Time Days

30

Number Of Sites

2

Number Of Participants

64

Primary sponsor

Full Name

Vaestra Goetalandsregionen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Sweden