Exebacase in Addition to Standard-of-Care Antibiotics for Staphylococcus aureus Bloodstream Infections and Right-Sided Infective Endocarditis: A Phase 3, Superiority-Design, Placebo-Controlled, Randomized Clinical Trial (DISRUPT).
Vance G FowlerAnita F DasJoy Lipka-DiamondJane E AmblerRaymond SchuchRoger PomerantzCara CassinoLuis Jáuregui-PeredoGregory J MoranMark E RuppAnne M LachiewiczJoseph L KutiRobert A WiseKeith S KayeMarcus J ZervosW Garrett NicholsPublished in: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America (2024)
Exebacase + antibiotics failed to improve clinical response at Day 14 in patients with MRSA bacteremia/endocarditis. This result was unexpected based on phase 2 data that established proof-of-concept for exebacase + antibiotics in patients with MRSA bacteremia/endocarditis. In the antibiotics alone group, the clinical response rate was higher than that seen in phase 2. Heterogeneity within the study population and a relatively small sample size in either the phase 2 or phase 3 studies may have increased the probability of imbalances in the multiple components of Day 14 clinical outcome. This study provides lessons for future superiority studies in S. aureus bacteremia/endocarditis.
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