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. Clinical Trials Registration.NCT04160468.
Keyphrases
- staphylococcus aureus
- clinical trial
- methicillin resistant staphylococcus aureus
- healthcare
- palliative care
- double blind
- placebo controlled
- randomized controlled trial
- single cell
- machine learning
- radiation therapy
- biofilm formation
- cystic fibrosis
- phase ii
- deep learning
- pain management
- current status
- chronic pain
- candida albicans
- phase iii
- cone beam