ERAdicate S. Aureus in Patients With Bacteremia and Endocarditis (ERASE)

Lysovant

Status and phase

Withdrawn

Phase 2

Conditions

Right Sided Infective Endocarditis (Disorder)

Endocarditis Infective

Left Sided Infective Endocarditis (Disorder)

Bacteremia Due to Staphylococcus Aureus

Treatments

Drug: Tonabacase (LSVT-1701)

Study type

Interventional

Funder types

Industry

Identifiers

NCT05329168

LSVT-1701-2001

Details and patient eligibility

About

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).

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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