MedTrace Logo

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

NCT03163446 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2021-10-08

Study results available
· View outcomes & findings →

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

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

Sponsors & Collaborators

  • ContraFect

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-23
Primary Completion
2019-03-07
Completion
2019-03-07
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Bulgaria
  • Chile
  • Czechia
  • France
  • Germany
  • Greece
  • Guatemala
  • Israel
  • Italy
  • Russia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03163446 on ClinicalTrials.gov