Summary

for people ages 18 years and up (full criteria)
at Sacramento, California and other locations
study started
completion

Description

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.

Official 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 Endocarditis

Keywords

Staphylococcus Aureus Bacteremia Staphylococcus Aureus Endocarditis Staphylococcus aureus bacteremia staphylococcal endocarditis Endocarditis Anti-Bacterial Agents

Eligibility

You can join if…

Open to people ages 18 years and up

  • male or female, 18 years or older
  • blood culture positive for S. aureus
  • at least one sign or symptom attributable to S. aureus bacteremia
  • known or suspected complicated S. aureus BSI and/or endocarditis by Modified Duke Criteria
  • patient is not pregnant or breastfeeding and is not of reproductive potential or agrees to use contraception if of reproductive potential.

You CAN'T join if...

  • patient previously received CF-301.
  • treatment with any potentially effective (anti-staphylococcal) systemic antibiotic for more than 72 hours within 7 days before randomization.
  • presence of any removable infection source that will not be removed or debrided within 72 hours after randomization.
  • brain abscess or meningitis.
  • community acquired pneumonia or known polymicrobial bacteremia

Locations

  • CF-301-102 Study Site
    Sacramento California 95817 United States
  • CF301-102 Study Site
    Sylmar California 91342 United States

Details

Status
accepting new patients
Start Date
Completion Date
Sponsor
ContraFect
Links
Sign up for this study
ID
NCT03163446
Phase
Phase 2
Study Type
Interventional
Last Updated