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

ContraFect

Status and phase: Completed; Phase 2

Conditions: Staphylococcus Aureus Endocarditis; Staphylococcus Aureus Bacteremia

Treatments: Drug: Placebo; Biological: CF-301

Study type: Interventional

Funder types: Industry

Identifiers

NCT03163446

CF-301-102

Details and patient eligibility

About

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.

Enrollment: 121 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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121 participants in 2 patient groups, including a placebo group

CF-301

Experimental group

Description:

Patients will receive a single IV infusion of CF-301 in addition to standard of care (SOC) antibacterial therapy selected by the investigator.

Treatment:

Biological: CF-301

Placebo

Placebo Comparator group

Description:

Patients will receive a single IV infusion of placebo in addition to standard of care (SOC) antibacterial therapy selected by the investigator.

Treatment:

Drug: Placebo