ERAdicate S. Aureus in Patients With Bacteremia and Endocarditis

Phase 2

Withdrawn

• Conditions: Right Sided Infective Endocarditis (Disorder); Bacteremia Due to Staphylococcus Aureus; Left Sided Infective Endocarditis (Disorder); Endocarditis Infective
• Interventions: Drug: Tonabacase (LSVT-1701)

• Registration Number: NCT05329168
• Lead Sponsor: Lysovant

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 Staphylococcus aureus bacteremia (SAB), including left- and right-sided infective endocarditis (IE).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-23
• Study First Submitted QC: 2022-04-08
• Study First Posted: 2022-04-14
• Study Start: 2022-05-01
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-27
• Last Update Posted: 2022-06-30
• Primary Completion: 2023-08-17
• Study Completion: 2023-11-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sequential ascending-dose cohort	Tonabacase (LSVT-1701)	Sequential ascending-dose cohort

Primary Outcome Measures

Name	Time	Method
Incidence of treatment-emergent adverse events coded per the Medical Dictionary of Regulatory Activities (MedDRA) v.24.0 [norm]	Up to Day 90±14
Incidence of Grade 3 or Grade 4 toxicity according to modified DAIDS criteria version 2.1	Up to 14±4 days after end of SOC antibiotic therapy (up to Day 42)
Changes in 12-lead electrocardiogram (ECG)	Day 1 and Day 2

Secondary Outcome Measures

Name	Time	Method
Maximum plasma concentration (Cmax) of LSVT-1701	Day 4
Area under the concentration-time curve (AUC) of LSVT-1701	Day 4
Overall clinical response	Day 7, Day 14, after end of SOC antibiotic therapy (up to Day 42), and at test of cure (TOC; 14 days after the EOT)	Overall clinical response is defined as survival, resolution or improvement of attributable signs and symptoms, no new attributable signs and symptoms, no new foci of S. aureus infection, no change in antibiotics due to non-response, and no further surgery or medical intervention to treat S. aureus.
Microbiological response rate	Days 3, 5, 7, 14, and up to Day 90

Trial Locations

Locations (1)

Lsvt-1701-2001; 🇺🇸 Butte, Montana, United States