Direct Lysis of Staph Aureus Resistant Pathogen Trial of Exebacase
NCT ID: NCT04160468
Last Updated: 2023-11-02
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
259 participants
INTERVENTIONAL
2019-12-20
2022-09-09
Brief Summary
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Exebacase, a direct lytic agent, is an entirely new treatment modality against S. aureus. Exebacase is a recombinantly-produced, purified cell wall hydrolase enzyme that results in rapid bacteriolysis, potent biofilm eradication, synergy with antibiotics, low propensity for resistance, and the potential to suppress antibiotic resistance when used together with antibiotics. Exebacase represents a first-in-field, first-in-class treatment with the potential to improve clinical outcome when used in addition to SoCA to treat S. aureus BSI including IE.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Exebacase
Exebacase
Participants will receive a single IV infusion of exebacase in addition to SoCA selected by the investigator. Participants with normal renal function or mild renal impairment will be administered a dose of 18 mg; participants with moderate or severe renal impairment will be administered a dose of 12 mg of exebacase; participants with end-stage renal disease, including those on hemodialysis, will be administered a dose of 8 mg of exebacase.
Placebo
Placebo
Participants will receive a single IV infusion of placebo in addition to SoCA selected by the investigator.
Interventions
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Exebacase
Participants will receive a single IV infusion of exebacase in addition to SoCA selected by the investigator. Participants with normal renal function or mild renal impairment will be administered a dose of 18 mg; participants with moderate or severe renal impairment will be administered a dose of 12 mg of exebacase; participants with end-stage renal disease, including those on hemodialysis, will be administered a dose of 8 mg of exebacase.
Placebo
Participants will receive a single IV infusion of placebo in addition to SoCA selected by the investigator.
Eligibility Criteria
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Inclusion Criteria
* Blood culture positive for S. aureus
* At least two signs or symptoms attributable to S. aureus BSI/IE
* Known or suspected complicated S. aureus BSI and/or right-sided IE based on Modified Duke Criteria
* Not pregnant or breastfeeding and not of reproductive potential or agrees to remain abstinent or use contraception if of reproductive potential
Exclusion Criteria
* Known or suspected left-sided IE
* Treatment with effective systemic anti-staphylococcal antibiotic for more than 72 hours within 7 days before randomization
* Presence of prosthetic valve or cardiac valve support ring, or presence of known or suspected infected hardware (orthopedic), prosthetic joint, or cardiac device
* Known polymicrobial BSI, or known ongoing systemic infection caused by other bacterial and/or fungal pathogen(s), and/or known to have coronavirus disease 2019 (COVID-19)
12 Years
ALL
No
Sponsors
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ContraFect
INDUSTRY
Responsible Party
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Locations
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Cf 301-105
Birmingham, Alabama, United States
CF-301-105 Study Site
Orange, California, United States
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Sacramento, California, United States
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San Diego, California, United States
CF-301-105 Investigator Site
Sylmar, California, United States
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Torrance, California, United States
CF-301-105 Study Site
Hartford, Connecticut, United States
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New Haven, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Washington D.C., District of Columbia, United States
Cf 301-105
Gainesville, Florida, United States
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Atlanta, Georgia, United States
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Augusta, Georgia, United States
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Decatur, Georgia, United States
CF-301-105 Study Site
Idaho Falls, Idaho, United States
CF-301-105 Investigator Site
Chicago, Illinois, United States
Cf 301-105
Glenview, Illinois, United States
Cf 301-105
Highland Park, Illinois, United States
Cf 301-105
Maywood, Illinois, United States
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Fort Wayne, Indiana, United States
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Kansas City, Kansas, United States
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Baltimore, Maryland, United States
Cf 301-105
Baltimore, Maryland, United States
CF 301-105 Study Site
Boston, Massachusetts, United States
CF-301-105 Study Site
Burlington, Massachusetts, United States
Cf 301-105
Worcester, Massachusetts, United States
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Detroit, Michigan, United States
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Royal Oak, Michigan, United States
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Rochester, Minnesota, United States
CF-301-105 Study Site
Columbia, Missouri, United States
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St Louis, Missouri, United States
CF-301-105 Study Site
Butte, Montana, United States
Cf 301-105
Omaha, Nebraska, United States
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Omaha, Nebraska, United States
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Neptune City, New Jersey, United States
Cf 301-105
Newark, New Jersey, United States
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New York, New York, United States
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Valhalla, New York, United States
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Chapel Hill, North Carolina, United States
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Charlotte, North Carolina, United States
Cf 301-105
Durham, North Carolina, United States
CF-301-105 Study Site
Greenville, North Carolina, United States
CF-301-105 Study Site
Columbus, Ohio, United States
Cf 301-105
Toledo, Ohio, United States
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Allentown, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
Cf 301-105
Philadelphia, Pennsylvania, United States
CF 301-105 Investigator Site
West Reading, Pennsylvania, United States
Cf 301-105
Memphis, Tennessee, United States
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Memphis, Tennessee, United States
Cf 301-105
Nashville, Tennessee, United States
Cf 301-105
Houston, Texas, United States
CF-301-105 Study Site
Salt Lake City, Utah, United States
Cf 301-105
Burlington, Vermont, United States
Cf 301-105
Milwaukee, Wisconsin, United States
Countries
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References
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Fowler VG Jr, Das AF, Lipka-Diamond J, Ambler JE, Schuch R, Pomerantz R, Cassino C, Jauregui-Peredo L, Moran GJ, Rupp ME, Lachiewicz AM, Kuti JL, Wise RA, Kaye KS, Zervos MJ, Nichols WG. Exebacase in Addition to Standard-of-Care Antibiotics for Staphylococcus aureus Bloodstream Infections and Right-Sided Infective Endocarditis: A Phase 3, Superiority-Design, Placebo-Controlled, Randomized Clinical Trial (DISRUPT). Clin Infect Dis. 2024 Jun 14;78(6):1473-1481. doi: 10.1093/cid/ciae043.
Traczewski MM, Ambler JE, Schuch R. Determination of MIC Quality Control Parameters for Exebacase, a Novel Lysin with Antistaphylococcal Activity. J Clin Microbiol. 2021 Jun 18;59(7):e0311720. doi: 10.1128/JCM.03117-20. Epub 2021 Jun 18.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CF-301-105
Identifier Type: -
Identifier Source: org_study_id
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