Direct Lysis of Staph Aureus Resistant Pathogen Trial of Exebacase

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Endocarditis

In brief

The purpose of this superiority study is to evaluate the efficacy and safety of exebacase in addition to standard of care antibiotics (SoCA) compared with SoCA alone for the treatment of patients with Staphylococcus aureus (S. aureus) bloodstream infections (BSI), including right-sided infective endocarditis (IE). Patients will be randomized to receive a single intravenous dose of exebacase or placebo. Patients will receive SoCA selected by the investigators based on the protocol. 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.

Key facts

Study ID

NCT04160468

Run by

ContraFect

People needed

259

Starts

2019-12-20

Expected to finish

2022-09-09

Last updated by the study team

2023-11-02

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, 12 years or older
• 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

You may not qualify if…

• Previously received exebacase
• 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)

Where it is running

• CF-301-105 Study Site — Orange, California, United States
• Cf 301-105 — Sacramento, California, United States
• Cf 301-105 — San Diego, California, United States
• CF-301-105 Investigator Site — Sylmar, California, United States
• Cf 301-105 — Torrance, California, United States
• CF-301-105 Study Site — Hartford, Connecticut, United States
• Cf 301-105 — New Haven, Connecticut, United States
• Cf 301-105 — Washington D.C., District of Columbia, United States
• Cf 301-105 — Washington D.C., District of Columbia, United States
• Cf 301-105 — Gainesville, Florida, United States
• Cf 301-105 — Atlanta, Georgia, United States
• Cf 301-105 — Augusta, Georgia, United States
• Cf 301-105 — 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
• Cf 301-105 — Fort Wayne, Indiana, United States
• Cf 301-105 — Kansas City, Kansas, United States
• Cf 301-105 — 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 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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