Direct Lysis of Staph Aureus Resistant Pathogen Trial of Exebacase — DISRUPT  

Staphylococcus Aureus Bacteremia Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Bacteremia
• Endocarditis
• Staphylococcal Infections
• Staphylococcus Aureus Bacteremia
• Staphylococcus Aureus Endocarditis

• NCT number: NCT04160468
• Study type: Interventional
• Source: ContraFect
• Status: Terminated
• Phase: Phase 3
• Start date: December 20, 2019
• Completion date: September 9, 2022