ERAdicate S. Aureus in Patients With Bacteremia and Endocarditis
Withdrawn before enrolling · Phase 2
Conditions studied: Bacteremia Due to Staphylococcus Aureus, Left Sided Infective Endocarditis (Disorder), Right Sided Infective Endocarditis (Disorder), Endocarditis Infective
In brief
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).
Key facts
- Study ID
- NCT05329168
- Run by
- Lysovant
- People needed
- 0
- Starts
- 2022-05-01
- Expected to finish
- 2023-11-01
- Last updated by the study team
- 2022-06-30
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Lsvt-1701-2001 — Butte, Montana, United States
Full record on ClinicalTrials.gov
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