Summary

Eligibility
for people ages 12 years and up (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
estimated completion

Description

Summary

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.

Official Title

A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of a Single Dose of Exebacase in Patients Receiving Standard-of-Care Antibiotics for the Treatment of Staphylococcus Aureus Bloodstream Infections (Bacteremia), Including Right-Sided Infective Endocarditis

Keywords

Staphylococcus Aureus Bacteremia Staphylococcus Aureus Endocarditis S. aureus bloodstream infection S. aureus bacteremia S. aureus right-sided infective endocarditis Staphylococcal Infections Bacteremia Endocarditis Exebacase

Eligibility

You can join if…

Open to people ages 12 years and up

  • 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 CAN'T join 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 orthopedic hardware, prosthetic joint, or cardiac device
  • Known or suspected brain abscess or meningitis
  • Known or suspected urinary tract infection or primary pneumonia as the sole source of
  • aureus BSI
  • Known polymicrobial BSI, or known ongoing systemic infection caused by other bacterial and/or fungal pathogen(s), and/or known to have COVID-19

Locations

  • Cf 301-105 accepting new patients
    Sacramento California 95817 United States
  • CF-301-105 Investigator Site accepting new patients
    Sylmar California 91342 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
ContraFect
Links
Sign up for this study
ID
NCT04160468
Phase
Phase 3
Study Type
Interventional
Last Updated