Periprosthetic hip or knee joint infections
Conditions
Interventions
Trade Name: Rimactan
Pharmaceutical Form: Capsule
INN or Proposed INN: RIFAMPICIN
CAS Number: 13292-46-1
Trade Name: Fucidin
Pharmaceutical Form: Tablet
INN or Proposed INN: FUSIDIC ACID
Other descri
Sponsors
Sahlgrenska University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be included in the study, subjects must meet the following criteria: • The subject has given written consent to participate in the study. • The subject suffers a first-time staphylococcal PJI in hip or knee according to Musculoskeletal Infection Society (MSIS) definitions • The subject has surgical treatment according to the DAIR principle • The PJI is mono-microbial • The subject undergoes 14 days of intravenous treatment with either cloxacillin or vancomycin • The subject receives standardized administration of local antibiotics Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 32 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 32
Exclusion criteria
Exclusion criteria: Subjects must not be included in the study if any of the following criteria are met: • experience allergy/previous toxic event/unacceptable drug interaction to most effective antibiotic combination according to either MIC or MBEC • experience severe drug interactions to MBEC-guided compound • pregnancy • woman of childbearing potential (WOCBP) A woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this prospective study is to compare 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.;Secondary Objective: The secondary objectives are: -to evaluate how treatment choice affects infection resolution, drug tolerability and resistance patterns of potential relapse strains. -to investigate the pathogenesis of PJI through the characterization of the virulence properties (e.g. biofilm formation ability, biofilm antimicrobial resistance, and production of toxins) carried by the clinical strains of Staphylococcus spp. isolated from PJI.;Primary end point(s): Proportions of antimicrobial regimens other than standard of care through application of proposed MBEC-algorithm.;Timepoint(s) of evaluation of this end point: 2 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 12 months follow-up for repeat procedure, relapse or reinfection, according to MSIS-criteria of PJI - PROMs - Time to revision: a shorter time could potentially indicate that the right decision is taken at an earlier stage - Resource consumption - Emerging bacterial resistance to any antimicrobial used in the study determined through biopsy cultures at relapse surgery;Timepoint(s) of evaluation of this end point: 12 months | — |
Countries
Sweden
Contacts
Public ContactStudy coordinator
Sahlgrenska University Hospital
Outcome results
None listed