Outcomes
bacteremia, infection, MSSA
ENDOCARDITIS, ADVERSE EVENTS, INFECTION, SECONDARY, STERILE
The primary study endpoint was treatment success at day 7, a composite endpoint defined as the presence of all of the following criteria: patient alive, stable or with improved qSOFA score compared with baseline, afebrile and with negative blood cultures for MSSA. The primary endpoint was adjudicated by an independent committee blinded to the antibiotic therapy received by participants. Withdrawal of study medication for any reason before day 7 was considered treatment failure. A hierarchical analysis of treatment success had been planned at TOC only if there had been statistical differences in the primary endpoint at day 7. The analysis at day 7 would provide an early indication of whether the antibiotic was effective in controlling the infection.The secondary clinical endpoints were all-cause mortality at day 7, end of therapy and TOC visits, persistent bacteremia (at least one positive blood culture) at day 3 and day 7 after randomization, microbiological treatment failure (defined as a positive sterile site culture for MSSA at least 14 days after randomization), relapsing bacteremia (defined as at least one positive blood culture for MSSA at least 72 h after a preceding negative culture) assessed at TOC, complicated bacteremia (defined as persistent bacteremia, endocarditis, metastatic emboli or the presence of prosthetic devices), emergence of fosfomycin-resistant strains, length of intensive care unit stay, duration of intravenous antibiotic treatment, and serious adverse events leading to discontinuation of therapy during the first 7 days after randomization.A systematic, prioritized, risk-based approach to the monitoring of adverse events was applied to ensure that the trial was conducted, recorded and reported in accordance with good clinical practicesAll data were recorded on a secure web application for building and managing online databases (REDCap)