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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
4.5 or 6.0 mg/kg IV once daily for 4 days
Lsvt-1701-2001
Butte, Montana, United States
Incidence of treatment-emergent adverse events coded per the Medical Dictionary of Regulatory Activities (MedDRA) v.24.0 [norm]
Time frame: Up to Day 90±14
Incidence of Grade 3 or Grade 4 toxicity according to modified DAIDS criteria version 2.1
Time frame: Up to 14±4 days after end of SOC antibiotic therapy (up to Day 42)
Changes in 12-lead electrocardiogram (ECG)
Time frame: Day 1 and Day 2
Maximum plasma concentration (Cmax) of LSVT-1701
Time frame: Day 4
Area under the concentration-time curve (AUC) of LSVT-1701
Time frame: Day 4
Overall clinical response
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.
Time frame: 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)
Microbiological response rate
Time frame: Days 3, 5, 7, 14, and up to Day 90
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