NCT03163446

Safety, Efficacy and Pharmacokinetics of CF-301 vs. Placebo in Addition to Antibacterial Therapy for Treatment of S. Aureus Bacteremia

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 Endocarditis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: ContraFect · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Staphylococcus Aureus Bacteremia
• Staphylococcus Aureus Endocarditis

Interventions

Type	Name	Description
BIOLOGICAL	CF-301	CF-301, 0.25 mg/kg, given as a single 2 hour iv infusion
DRUG	Placebo	Placebo, given as a single 2 hour iv infusion

Timeline

• Start date: 2017-05-23
• Primary completion: 2019-03-07
• Completion: 2019-03-07
• First posted: 2017-05-23
• Last updated: 2021-10-08
• Results posted: 2021-10-08

Locations

78 sites across 14 countries: United States, Belgium, Bulgaria, Chile, Czechia, France, Germany, Greece, Guatemala, Israel, Italy, Russia, Spain, United Kingdom

Regulatory

• FDA-regulated drug study