NCT04160468

Direct Lysis of Staph Aureus Resistant Pathogen Trial of Exebacase

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 259 (actual)
• Sponsor: ContraFect · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Staphylococcus Aureus Bacteremia
• Staphylococcus Aureus Endocarditis

Interventions

Type	Name	Description
DRUG	Exebacase	Participants will receive a single IV infusion of exebacase in addition to SoCA selected by the investigator. Participants with normal renal function or mild renal impairment will be administered a dose of 18 mg; participants with moderate or severe renal impairment will be administered a dose of 12 mg of exebacase; participants with end-stage renal disease, including those on hemodialysis, will be administered a dose of 8 mg of exebacase.
DRUG	Placebo	Participants will receive a single IV infusion of placebo in addition to SoCA selected by the investigator.

Timeline

• Start date: 2019-12-20
• Primary completion: 2022-09-09
• Completion: 2022-09-09
• First posted: 2019-11-13
• Last updated: 2023-11-02
• Results posted: 2023-10-18

Locations

55 sites across 1 country: United States

Regulatory

• FDA-regulated drug study