Efficay and safety of ampicillin and ceftriaxone continuous infusion versus standard therapy for the treatment of Enterococcus faecalis infective endocarditis (DOβLEI Study)

简要总结

主要结局

次要结局

• Treatment failure assessed up to one year after completion of treatment and defined as follows: mortality (therapeutic failure) from any cause during hospitalization or from endocarditis-related causes throughout the study.
• Number of unplanned cardiac surgeries during the entire study.
• Number of unplanned readmissions during the entire trial.
• Number of medication-related adverse events from randomisation until 30 days after the last dose administered.
• Total number of antibiotic treatment days, number of TADE treatment days in those patients who receive continuous infusion (experimental arm) and their site has a TADE programme, and number of healthcare-associated infections throughout the trial.
• Confirmed recurrence of Enterococcus faecalis infective endocarditis throughout the study.
• Minimum free serum concentration and steady-state plasma concentration of ceftriaxone and ampicillin for 24 hours on day 14 after initiation of treatment (visit 2) in the experimental arm.
• Pharmacokinetic parameters (volume of distribution, clearance, elimination constant) of ceftriaxone and ampicillin on day 14 after initiation of treatment (visit 2).
• Synergistic activity will be calculated through the reduction of the Minimum Inhibitory Concentration of ampicillin induced by ceftriaxone in the strains responsible for recurrences and control strains.