business decision before FPFV; not related to any safety concerns

This study evaluates safety and tolerability of endolysin-derived LSVT-1701 (tonabacase) as an add-on to standard of care (SOC) antibiotic therapy for the treatment of patients with complicated Staphylococcus aureus bacteremia (SAB), including left- and right-sided infective endocarditis (IE).

Inclusion Criteria:

• Age of 18 to 90 years
• Index blood culture collection within 96 hours prior to enrollment positive for S. aureus
• Experienced at least one sign or symptom related to SAB within past 96 hours prior to enrollment
• Known or suspected left- and/or right-sided endocarditis by modified Duke criteria and/or known or suspected complicated SAB
• Required duration of SOC antibiotic therapy ≤ 42 days

Exclusion Criteria:

• Previous receipt of LSVT-1701 or CF-301 (exebacase)
• Known hypersensitivity to kanamycin or other aminoglycosides
• Treatment with any potentially effective (anti-S. aureus) systemic antibiotic for > 96 hours within 7 days before enrollment. Exception: Persistent S. aureus bacteremia after 96 hours of prior appropriate systemic antistaphylococcal antibiotic, and/or resistance to the prior systemic antibiotic
• Treatment with dalbavancin or oritavancin within the previous 90 days
• Known or suspected brain abscess or meningitis
• Community acquired pneumonia, nosocomial pneumonia because of pathogens other than S. aureus, or known polymicrobial bacteremia
• Presence of an intravascular infection source or extravascular material that cannot be removed within 96 hours after enrollment