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

Completed · Phase 2 · Has a placebo group

Conditions studied: Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Endocarditis

In brief

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.

Key facts

Study ID

NCT03163446

Run by

ContraFect

People needed

121

Starts

2017-05-23

Expected to finish

2019-03-07

Last updated by the study team

2021-10-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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

Where it is running

• 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 — 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
• CF301-102 Study Site — Burlington, Massachusetts, United States
• CF-301-102 Study Site — Detroit, Michigan, United States
• CF301-102 Study Site — Royal Oak, Michigan, United States
• CF301-102 Study Site — St Louis, Missouri, United States
• CF301-102 Study site — Butte, Montana, United States
• CF301-102 Study Site — Omaha, Nebraska, United States
• CF-301-102 Study Site — Omaha, Nebraska, United States
• CF-301-102 Study Site — Englewood, New Jersey, United States
• CF301-102 Study Site — Paterson, New Jersey, United States
• CF-301-102 Study Site — New York, New York, United States
• CF-301-102 Study Site — New York, New York, United States
• CF-301-102 Study Site — Valhalla, New York, United States
• CF-301-102 Study Site — Cleveland, Ohio, United States
• CF301-102 Study Site — Columbus, Ohio, United States
• Cf-301-102 — Columbus, Ohio, United States
• CF-301-102 Study Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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