Direct Lysis of Staph Aureus Resistant Pathogen Trial of Exebacase (DISRUPT)

  • STATUS
    Not Recruiting
  • days left to enroll
    89
  • participants needed
    348
  • sponsor
    ContraFect
Updated on 19 August 2022

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 on19 August 2022

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