A Phase 2 interventional study of Tonabacase (LSVT-1701) in Bacteremia Due to Staphylococcus Aureus, Left Sided Infective Endocarditis (Disorder) and Right Sided Infective Endocarditis (Disorder), sponsored by Lysovant. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2022-06-30.
Sponsored by Lysovant · Phase 2, Interventional, and Treatment
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).
173 studies on the registry are indexed under Endocarditis; 57 are open to participants now.
Browse Endocarditis studies →This is the only study on the registry with Lysovant as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sequential ascending-dose cohort
Drug: Tonabacase (LSVT-1701)
4.5 or 6.0 mg/kg IV once daily for 4 days
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
Overall clinical response in patients with left-sided endocarditis
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: Up to Day 14
Overall clinical response in patients with right-sided endocarditis
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: Up to Day 14
All-cause mortality
Time frame: Day 14 and Day 28
Mortality attributable to SAB
Time frame: Day 14 and Day 28
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for May 2022; primary completion for Aug 2023, 15 months later.
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This study is withdrawn, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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