Direct Lysis of Staph Aureus Resistant Pathogen Trial of Exebacase

Phase 3

Terminated

• Conditions: Staphylococcus Aureus Bacteremia; Staphylococcus Aureus Endocarditis
• Interventions: Drug: Placebo; Drug: Exebacase

• Registration Number: NCT04160468
• Lead Sponsor: ContraFect

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-07
• Study First Submitted QC: 2019-11-08
• Study First Posted: 2019-11-13
• Study Start: 2019-12-20
• Primary Completion: 2022-09-09
• Study Completion: 2022-09-09
• Results First Submitted: 2023-09-23
• Results First Submitted QC: 2023-09-23
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-17
• Results First Posted: 2023-10-18
• Last Update Posted: 2023-11-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 259

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Exebacase	Exebacase	-

Primary Outcome Measures

Name	Time	Method
Clinical Responder Rate at Day 14 in the MRSA Population in the Microbiological Intent-to-treat (mITT) Analysis Set	Day 14	Clinical outcome of responder was defined as survival with resolution or 2-grade improvement of attributable signs and symptoms and negative blood cultures by Day 14, and without new signs or symptoms, new metastatic foci or septic emboli, or change in antibiotics due to lack of response.
Treatment-emergent Adverse Events (TEAEs) Through Day 60	Through Day 60	Number and percentage of patients with treatment-emergent adverse events (TEAEs)

Trial Locations

Locations (5)

CF-301-105 Investigator Site; 🇺🇸 Chicago, Illinois, United States

CF 301-105 Study Site; 🇺🇸 Boston, Massachusetts, United States

CF-301-105 Study Site; 🇺🇸 Salt Lake City, Utah, United States

Cf 301-105; 🇺🇸 Milwaukee, Wisconsin, United States

CF 301-105 Investigator Site; 🇺🇸 West Reading, Pennsylvania, United States