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

ContraFect

Status and phase

Terminated

Phase 3

Conditions

Staphylococcus Aureus Endocarditis

Staphylococcus Aureus Bacteremia

Treatments

Drug: Placebo

Drug: Exebacase

Study type

Interventional

Funder types

Industry

Identifiers

NCT04160468

CF-301-105

Details and patient eligibility

About

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.

Enrollment

259 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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 hardware (orthopedic), prosthetic joint, or cardiac device
Known polymicrobial BSI, or known ongoing systemic infection caused by other bacterial and/or fungal pathogen(s), and/or known to have coronavirus disease 2019 (COVID-19)