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 accepting new patients
    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
Participants
Expecting 12 study participants
Last Updated