ERAdicate S. Aureus in Patients With Bacteremia and Endocarditis
NCT ID: NCT05329168
Last Updated: 2022-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2022-05-01
2023-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Sequential ascending-dose cohort
Sequential ascending-dose cohort
Tonabacase (LSVT-1701)
4.5 or 6.0 mg/kg IV once daily for 4 days
Interventions
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Tonabacase (LSVT-1701)
4.5 or 6.0 mg/kg IV once daily for 4 days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
90 Years
ALL
No
Sponsors
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Lysovant
INDUSTRY
Responsible Party
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Locations
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Lsvt-1701-2001
Butte, Montana, United States
Countries
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Other Identifiers
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LSVT-1701-2001
Identifier Type: -
Identifier Source: org_study_id
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