Lysin CF-301 for Treatment of Staphylococcus aureus bacteremia
Research type
Research Study
Full title
A Multicenter, Double-Blind, Randomized, Comparative Study of the Safety, Tolerability, Efficacy, and Pharmacokinetics of CF 301 vs. Placebo in Addition to Standard-of-Care Antibacterial Therapy for the Treatment of Adult Patients with Staphylococcus aureus Bloodstream Infections (Bacteremia) Including Right-Sided Endocarditis
IRAS ID
215915
Contact name
Matthew Scarborough
Contact email
Sponsor organisation
ContraFect Corporation
Eudract number
2016-003059-31
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 9 months, 30 days
Research summary
This is an international, randomized, double-blind, placebo-controlled study to evaluate CF-301 vs. placebo used in addition to standard of care (SOC) antibiotics for the treatment of adult patients with Staphylococcus aureus (S. aureus) Bloodstream Infections (Bacteremia) Including Right-Sided Endocarditis.
CF-301 is a member of a new class of recombinantly-produced, protein-based therapies called bacteriophage-derived lysins. CF-301 is an enzyme that ruptures the cell wall of S. aureus, and causes the bacteria to die. Lysins are highly targeted to specific bacterial species. CF-301 is different from current standard of care antibiotics due to: (1) its novel mechanism of action; (2) bactericidal activity against resistant S. aureus; (3) rapid antibacterial activity in both laboratory and in infected animal studies; (4) narrow lytic (cell breakdown) action; (5) potent activity against biofilms; (6) synergistic activity with standard of care antibiotics (oxacillin, vancomycin, and daptomycin); (7) low tendency to develop bacterial resistance; and (8) ability to protect against the emergence of resistance to standard of care antibiotic therapies when used in combination.
Approximately 115 patients will be randomized in a 3:2 ratio to one of two treatment groups. Group 1: CF-301 (70 patients); Group 2: Placebo (45 patients). All patients will receive SOC antibacterial therapy. A single dose of CF-301 or placebo will be given directly into the vein through an intravenous catheter over a 2 hour period. Once the study has ended participants can request to be informed whether they received CF0301 or placebo.
Participation in the main part of the Study is expected to last about 8 to 10 weeks. Safety, efficacy and pharmacokinetics will be evaluated at specific time points. An additional follow up visit approximately 6 months after Study Drug administration will also be required.
This study is sponsored by ContraFect Corporation.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
17/EM/0313
Date of REC Opinion
22 Sep 2017
REC opinion
Further Information Favourable Opinion