Trials / Withdrawn
WithdrawnNCT05329168
ERAdicate S. Aureus in Patients With Bacteremia and Endocarditis
An Open-Label, Multiple-Ascending Dose, Multicenter Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LSVT-1701 as an Add-on to Standard of Care Antibiotics for the Treatment of Complicated Methicillin-Sensitive and -Resistant Staphylococcus Aureus Bacteremia Including Left- and Right-sided Infective Endocarditis
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Lysovant · Industry
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Not accepted
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).
Conditions
- Bacteremia Due to Staphylococcus Aureus
- Left Sided Infective Endocarditis (Disorder)
- Right Sided Infective Endocarditis (Disorder)
- Endocarditis Infective
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tonabacase (LSVT-1701) | 4.5 or 6.0 mg/kg IV once daily for 4 days |
Timeline
- Start date
- 2022-05-01
- Primary completion
- 2023-08-17
- Completion
- 2023-11-01
- First posted
- 2022-04-14
- Last updated
- 2022-06-30
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05329168. Inclusion in this directory is not an endorsement.