Bacteremia Due to Staphylococcus AureusPhase 2ERASENCT05329168
ERAdicate S. Aureus in Patients With Bacteremia and Endocarditis
A Phase 2 study testing Tonabacase (LSVT-1701) in people with Bacteremia Due to Staphylococcus Aureus and Left Sided Infective Endocarditis (Disorder), run by Lysovant at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Bacteremia Due to Staphylococcus Aureus, Left Sided Infective Endocarditis (Disorder), Right Sided Infective Endocarditis (Disorder)
- What is being tested?
- Tonabacase (LSVT-1701)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2022to 1 Nov 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Tonabacase (LSVT-1701)
- Keywords
- Staphylococcus aureus bacteremia, left-sided endocarditis, right-sided endocarditis, SAB
- Medical subject headings
- Endocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tonabacase (LSVT-1701)Drug
4.5 or 6.0 mg/kg IV once daily for 4 days
| Study group | Role | What they receive |
|---|---|---|
| Sequential ascending-dose cohort | Experimental | Sequential ascending-dose cohort Receives: Drug: Tonabacase (LSVT-1701) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events coded per the Medical Dictionary of Regulatory Activities (MedDRA) v.24.0 [norm]
Measured: Up to Day 90±14
Incidence of Grade 3 or Grade 4 toxicity according to modified DAIDS criteria version 2.1
Measured: Up to 14±4 days after end of SOC antibiotic therapy (up to Day 42)
Changes in 12-lead electrocardiogram (ECG)
Measured: Day 1 and Day 2
Secondary outcomes (4)
Maximum plasma concentration (Cmax) of LSVT-1701
Measured: Day 4
Area under the concentration-time curve (AUC) of LSVT-1701
Measured: Day 4
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.
Measured: 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)
Microbiological response rate
Measured: Days 3, 5, 7, 14, and up to Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start1 May 2022 (estimated)
- Primary completion17 Aug 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Why it stopped: business decision before FPFV; not related to any safety concerns
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacteremia Due to Staphylococcus AureusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Sequential ascending-dose
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lysovant
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05329168
- Sponsor's protocol ID
- LSVT-1701-2001
- Acronym
- ERASE
- Status last verified
- Jun 2022
- First submitted
- 23 Mar 2022
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05329168
- Acronym / sponsor ID
- ERASE / LSVT-1701-2001
- Conditions
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: business decision before FPFV; not related to any safety concerns
- Enrolment
- 0 participants (actual)
- Lead sponsor
- LysovantIndustry (pharma, biotech, devices)
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 17 Aug 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 14 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Sequential ascending-dose
| Arm | Type | Receives |
|---|---|---|
| Sequential ascending-dose cohort | Experimental | Drug: Tonabacase (LSVT-1701)Sequential ascending-dose cohort |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tonabacase (LSVT-1701)4.5 or 6.0 mg/kg IV once daily for 4 days | Drug | Sequential ascending-dose cohort |
Primary outcome
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
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)
Changes in 12-lead electrocardiogram (ECG)
Time frame: Day 1 and Day 2
4 secondary outcomes
Maximum plasma concentration (Cmax) of LSVT-1701
Time frame: Day 4
Area under the concentration-time curve (AUC) of LSVT-1701
Time frame: Day 4
Overall clinical response
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)
Microbiological response rate
Time frame: Days 3, 5, 7, 14, and up to Day 90
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tonabacase (LSVT-1701) in people with Bacteremia Due to Staphylococcus Aureus and Left Sided Infective Endocarditis (Disorder), run by Lysovant at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2022.