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Sequential ascending-dose cohort for Infective Endocarditis (ERASE Trial)

Phase 2
Waitlist Available
Research Sponsored by Lysovant
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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)
Awards & highlights

ERASE Trial 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).

Eligible Conditions
  • Infective Endocarditis
  • Staphylococcal Bacteremia

ERASE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in 12-lead electrocardiogram (ECG)
Incidence of Grade 3 or Grade 4 toxicity according to modified DAIDS criteria version 2.1
Incidence of treatment-emergent adverse events coded per the Medical Dictionary of Regulatory Activities (MedDRA) v.24.0 [norm]
Secondary outcome measures
Area under the concentration-time curve (AUC) of LSVT-1701
Maximum plasma concentration (Cmax) of LSVT-1701
Microbiological response rate
+1 more
Other outcome measures
All-cause mortality
Mortality attributable to SAB
Overall clinical response in patients with left-sided endocarditis
+1 more

ERASE Trial Design

1Treatment groups
Experimental Treatment
Group I: Sequential ascending-dose cohortExperimental Treatment1 Intervention
Sequential ascending-dose cohort

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Who is running the clinical trial?

LysovantLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
ERAdicate S. Aureus in Patients With Bacteremia and Endocarditis
2022. "ERAdicate S. Aureus in Patients With Bacteremia and Endocarditis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05329168.
~0 spots leftby Apr 2025
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