Direct Lysis of Staph Aureus Resistant Pathogen Trial of Exebacase

  • STATUS
    Recruiting
  • End date
    Nov 15, 2022
  • participants needed
    348
  • sponsor
    ContraFect
Updated on 1 November 2021

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.

Details
Condition Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Endocarditis
Treatment Placebo, Exebacase
Clinical Study IdentifierNCT04160468
SponsorContraFect
Last Modified on1 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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 S. 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
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