Summary

Eligibility
for people ages 18-90 (full criteria)
Location
at Butte, Montana
Dates
study started
estimated completion

Description

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).

Official Title

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

Keywords

Bacteremia Due to Staphylococcus Aureus, Left Sided Infective Endocarditis (Disorder), Right Sided Infective Endocarditis (Disorder), Endocarditis Infective, Staphylococcus aureus bacteremia, left-sided endocarditis, right-sided endocarditis, SAB, Staphylococcal Infections, Bacteremia, Endocarditis, Bacterial, Endocarditis, Disease, Tonabacase (LSVT-1701)

Eligibility

You can join if…

Open to people ages 18-90

  • 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

You CAN'T join if...

  • 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

Location

  • Lsvt-1701-2001
    Butte Montana 59701 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Lysovant
Links
Sign up for this study
ID
NCT05329168
Phase
Phase 2 research study
Study Type
Interventional
Last Updated