Rifampin-free regimen versus rifampin-containing regimen in the treatment of staphylococcal prosthetic valve endocarditis: a multicenter randomized controlled non-inferiority study (RIFREE)

staphylococcal endocarditis

All-cause mortality rate at 6 months post randomization

1)a)Within 6 months after randomization: Proportions of patients with at least one microbiological failure defined by bacteremia with the primary pathogen obtained during follow-up but before the end of curative treatment, 1)b)Within 6 months after randomization: Proportions of patients with at least one relapse defined by bacteremia with the primary pathogen obtained during follow-up after the end of treatment of endocarditis, 1)c)Within 6 months after randomization: Proportions of patients with at least one clinically evident embolic event defined as secondary osteoarticular, splenic, brain or other symptomatic localizations, 1)d)Within 6 months after randomization: Proportions of patients with at least one valvular surgery, 1)e)Within 6 months after randomization: Proportions of patients with clinical failure defined by a composite criterion: all-cause mortality or microbiological failure or relapse or embolic event or valvular surgery, 1)f)Within 6 months after randomization: Time to clinical failure, 1)g)Within 6 months after randomization: Proportions of patients with at least one adverse event grade III/IV related to treatment, 1)h)Within 6 months after randomization: Proportions of patients with at least one bleeding complication, 1)i)Within 6 months after randomization: Length of stay in hospital, 1)j)Within 6 months after randomization: Duration of curative antibiotic treatment for endocarditis, 2)All-cause mortality rates at discharge and at 3 months after randomization, 3)a) Within 12 months after randomization: Proportions of patients with at least one readmission in hospital (whatever the reason), 3)b)Within 12 months after randomization: Proportions of patients with at least one valvular surgery, 3)c)Within 12 months after randomization: All-cause mortality rates, 3)d)Within 12 months after randomization: Proportions of patients with at least one relapse, 4) Microbiological analysis of relapse: Proportions of patients with reclassification of relapse/failure as reinfection, Identification of clinical and biological factors associated with relapse, Proportions of patients with relapse in patients with surgery and without surgery, Identify a common heritable trait in the staphylococcal strains associated with the occurrence of relapse, 5)Incremental cost-effectiveness ratio (cost per quality-adjusted life year (QALYs) gained) comparing the two arms.

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