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Metadata

Name
Direct Lysis of Staph Aureus Resistant Pathogen Trial of Exebacase
Repository
ClinicalTrials.gov
Identifier
clinicaltrials:NCT04160468
Description
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.
Data or Study Types
clinical trial
Keywords
S. aureus bloodstream infection, S. aureus bacteremia, S. aureus right-sided infective endocarditis
Source Organization
Unknown
Access Conditions
available
Year
2019
Access Hyperlink
https://clinicaltrials.gov/ct2/show/NCT04160468

Distributions

  • Encoding Format: HTML ; URL: https://clinicaltrials.gov/ct2/show/results/NCT04160468
This project was funded in part by grant U24AI117966 from the NIH National Institute of Allergy and Infectious Diseases as part of the Big Data to Knowledge program. We thank all members of the bioCADDIE community for their valuable input on the overall project.