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ERAdicate S. Aureus in Patients With Bacteremia and Endocarditis (ERASE)

Primary Purpose

Bacteremia Due to Staphylococcus Aureus, Left Sided Infective Endocarditis (Disorder), Right Sided Infective Endocarditis (Disorder)

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tonabacase (LSVT-1701)
Sponsored by
Lysovant
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacteremia Due to Staphylococcus Aureus focused on measuring Staphylococcus aureus bacteremia, left-sided endocarditis, right-sided endocarditis, SAB

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Lsvt-1701-2001

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sequential ascending-dose cohort

Arm Description

Sequential ascending-dose cohort

Outcomes

Primary Outcome Measures

Incidence of treatment-emergent adverse events coded per the Medical Dictionary of Regulatory Activities (MedDRA) v.24.0 [norm]
Incidence of Grade 3 or Grade 4 toxicity according to modified DAIDS criteria version 2.1
Changes in 12-lead electrocardiogram (ECG)

Secondary Outcome Measures

Maximum plasma concentration (Cmax) of LSVT-1701
Area under the concentration-time curve (AUC) of LSVT-1701
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.
Microbiological response rate

Full Information

First Posted
March 23, 2022
Last Updated
June 27, 2022
Sponsor
Lysovant
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1. Study Identification

Unique Protocol Identification Number
NCT05329168
Brief Title
ERAdicate S. Aureus in Patients With Bacteremia and Endocarditis
Acronym
ERASE
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Withdrawn
Why Stopped
business decision before FPFV; not related to any safety concerns
Study Start Date
May 1, 2022 (Anticipated)
Primary Completion Date
August 17, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lysovant

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacteremia Due to Staphylococcus Aureus, Left Sided Infective Endocarditis (Disorder), Right Sided Infective Endocarditis (Disorder), Endocarditis Infective
Keywords
Staphylococcus aureus bacteremia, left-sided endocarditis, right-sided endocarditis, SAB

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Sequential ascending-dose
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sequential ascending-dose cohort
Arm Type
Experimental
Arm Description
Sequential ascending-dose cohort
Intervention Type
Drug
Intervention Name(s)
Tonabacase (LSVT-1701)
Intervention Description
4.5 or 6.0 mg/kg IV once daily for 4 days
Primary Outcome Measure Information:
Title
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
Title
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)
Title
Changes in 12-lead electrocardiogram (ECG)
Time Frame
Day 1 and Day 2
Secondary Outcome Measure Information:
Title
Maximum plasma concentration (Cmax) of LSVT-1701
Time Frame
Day 4
Title
Area under the concentration-time curve (AUC) of LSVT-1701
Time Frame
Day 4
Title
Overall clinical response
Description
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)
Title
Microbiological response rate
Time Frame
Days 3, 5, 7, 14, and up to Day 90
Other Pre-specified Outcome Measures:
Title
Overall clinical response in patients with left-sided endocarditis
Description
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
Title
Overall clinical response in patients with right-sided endocarditis
Description
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
Title
All-cause mortality
Time Frame
Day 14 and Day 28
Title
Mortality attributable to SAB
Time Frame
Day 14 and Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Lsvt-1701-2001
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

ERAdicate S. Aureus in Patients With Bacteremia and Endocarditis

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