Joint prosthesis infection after total hip and knee arthroplasty.
Conditions
Interventions
Trade Name: Rimactan
Product Name: Rimactan
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Rifampicin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Sponsors
Ullevål University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: We will include patients with the diagnosis of prosthetic joint infections category 2 or 3 after total hip or knee replacement. Patients with clinical signs of infection (persisting local pain, erythema, warmth, wound healing disturbance, effusion and fever) with or without raised CRP, are scheduled for soft tissue revision. Diagnosis of staphylococci must be established by arthrocentesis or at surgical revision, and stapylococci must grow in at least 2/8 cultures. The infection must be diagnosed within 4 weeks of index operation or presumed debut of a hematogenous infection. The prosthesis must be stable and left in place after soft tissue revision. We will include patients from 10 different hospitals in Norway, and written informed consent will be required for all the study patients. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusions criteria will be: Infection with microorganisms other than staphylococci, less than 2 years of expected survival, predictable inability to comply with the treatment and/or follow-up, contraindications to the use of rifampin, cloxacillin or vancomycin, acute or chronic liver disease, lack of written consent, fertile women, patients taking less than 80% of the study medication, and antimicrobial therapy during the last 2 weeks before surgical revision.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the clinical effiacy of rifampin-combination therapy versus monotherapy using cloxacillin or vancomycin in early stahylococcal infections after total hip and knee arthroplasty.;Secondary Objective: ;Primary end point(s): The study end point is cure of infection at the final follow-up visit two years after study entry. Cure is defined as the lack of clinical signs and symptoms of infections (fever, pain, redness, warmth, sinus tract), CRP<10mg/L, SR as prior to index operation and the absence of radiological signs of loosening or dislocation at 2 years follow-up. Confirmed failure is defined as revision and isolation of the initial microorganism or other microorganism in the culture of intraoperative tissue specimens, synovia or device during the 2 year study period. Probably failure is defined as clinical signs and symptoms of local infection, radiologic signs of loosening of the implant or an otherwise unexplained increase of CRP level or SR during the 2 year study period without microbiological documentation of infection. | — |
Countries
Norway
Outcome results
None listed