Status:
WITHDRAWN
ERAdicate S. Aureus in Patients With Bacteremia and Endocarditis
Lead Sponsor:
Lysovant
Conditions:
Bacteremia Due to Staphylococcus Aureus
Left Sided Infective Endocarditis (Disorder)
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief Summary
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 Staphy...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05329168
Start Date
May 1 2022
End Date
November 1 2023
Last Update
June 30 2022
Active Locations (1)
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1
Lsvt-1701-2001
Butte, Montana, United States, 59701