The purpose of this study is to evaluate the safety, tolerability, efficacy and pharmacokinetics (PK) of CF-301 in addition to background standard of care (SOC) antibacterial therapy for the treatment of Staphylococcus aureus (S. aureus) bloodstream infections (bacteremia), including endocarditis in adults. Patients will be randomized to receive a single intravenous dose of CF-301 or placebo in addition to SOC antibacterial therapy. Patients will be prescribed standard of care antibiotics selected by the investigators based on their professional experience, practice guidelines and local antibiotic susceptibility information for the treatment of S. aureus bacteremia. CF-301 is a lysin and member of a new class of targeted protein-based antimicrobials that has demonstrated activity against S. aureus in laboratory (in vitro) and animal studies, alone and in addition to conventional antibiotics.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
121
CF-301-102 Study Site
Birmingham, Alabama, United States
CF-301-102 Study Site
Sacramento, California, United States
CF301-102 Study Site
Sylmar, California, United States
CF-301-102 Study Site
New Haven, Connecticut, United States
CF-301-102 Study Site
Newark, Delaware, United States
CF-301-102 Study Site
Incidence of Adverse Events [Safety and Tolerability]
Number and percentage of patients with treatment-emergent adverse events (TEAEs)
Time frame: Through Day 7, at Test of Cure (TOC) between 56-70 days, and at Day 180
Clinical Outcome at Day 14
Description of clinical outcome in the Microbiological Intent-to-Treat (mITT) population. Responder (clinical outcome of improvement or response) was defined as survival with improvement or resolution of attributable signs and symptoms, and without new signs or symptoms, new foci of infection, change in antibiotics due to non-response, complications of S. aureus, or further surgery or medical intervention to treat S. aureus.
Time frame: Day 14
CF-301 Maximum Plasma Concentration (Cmax)
CF-301 plasma concentrations at specified timepoints.
Time frame: Pre-dose and at 0.5, 1.5, 2, 2.25, 3, 4, 8, 14, 24, and 48 hours after the start of CF-301 infusion
CF-301 Area Under the Curve (AUC 0-t)
CF-301 plasma concentrations at specified time points
Time frame: Pre-dose and at 0.5, 1.5, 2, 2.25, 3, 4, 8, 14, 24, and 48 hours after the start of CF-301 infusion
Clinical Outcome at Day 7
Description of clinical outcome in the mITT population. Responder (clinical outcome of improvement or response) was defined as survival with improvement or resolution of attributable signs and symptoms, and without new signs or symptoms, new foci of infection, change in antibiotics due to non-response, complications of S. aureus, or further surgery or medical intervention to treat S. aureus.
Time frame: Day 7
Clinical Outcome at End of Standard of Care Antibacterial Therapy (EOT)
Description of clinical outcome in the mITT population. Responder (clinical outcome of improvement or response) was defined as survival with improvement or resolution of attributable signs and symptoms, and without new signs or symptoms, new foci of infection, change in antibiotics due to non-response, complications of S. aureus, or further surgery or medical intervention to treat S. aureus.
Time frame: EOT between 28-42 days
Clinical Outcome at Test of Cure (TOC)
Description of clinical outcome in the mITT population. Responder (clinical outcome of improvement or response) was defined as survival with improvement or resolution of attributable signs and symptoms, and without new signs or symptoms, new foci of infection, change in antibiotics due to non-response, complications of S. aureus, or further surgery or medical intervention to treat S. aureus.
Time frame: TOC between 56-70 days
Clearance of Bacteremia at Day 7 After CF-301/Placebo Administration
Number and percentage of patients with clearance of bacteremia in the mITT population
Time frame: Day 7
Clearance of Bacteremia at Day 14 After CF-301/Placebo Administration
Number and percentage of patients with clearance of bacteremia in the mITT population
Time frame: Day 14
Microbiological Eradication at End of Standard of Care Antibacterial Therapy (EOT)
Number and percentage of patients with microbiological eradication in the mITT population
Time frame: EOT between 28-42 days
Microbiological Eradication at Test of Cure (TOC)
Number and percentage of patients with microbiological eradication in the mITT population
Time frame: TOC between 56-70 days
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Atlanta, Georgia, United States
CF-301-102 Study Site
Augusta, Georgia, United States
CF0301-102 Study Site
Decatur, Georgia, United States
CF-301 Study Site
Idaho Falls, Idaho, United States
CF301-102 Study Site
Chicago, Illinois, United States
...and 68 more locations