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

September 10, 2021 updated by: ContraFect

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

121

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
        • CF-301-102 Study Site #2
      • Brussels, Belgium
        • CF301-102 Study Site
      • Edegem, Belgium
        • CF301-102 Study Site
      • Ghent, Belgium
        • CF301-102 Study Site
      • Leuven, Belgium
        • CF301-102 Study Site
  • Bulgaria
      • Ruse, Bulgaria
        • CF301-102 Study Site
      • Sofia, Bulgaria
        • CF301-102 Study Site
  • Chile
      • Santiago, Chile
        • CF-301-102 Study Site
      • Viña Del Mar, Chile
        • CF-301-102 Study Site
  • Czechia
      • Brno, Czechia
        • CF301-102 Study Site
      • Prague, Czechia
        • CF301-102 Study Site #2
      • Prague, Czechia
        • CF301-102 Study Site
  • France
      • Limoges, France
        • CF301-102 Study Site
      • Lyon, France
        • CF301-102 Study Site
      • Paris, France
        • CF301-102 Study Site
      • Toulon, France
        • CF301-102 Study Site
  • Germany
      • Berlin, Germany
        • CF-301-102 Study Site #2
      • Berlin, Germany
        • CF-301-102 Study Site
      • Cologne, Germany
        • CF-301-102 Study Site
      • Freiburg, Germany
        • CF-301-102 Study Site
  • Greece
      • Athens, Greece
        • CF301-102 Study Site #3
      • Athens, Greece
        • CF301-102 Study Site
      • Athens, Greece
        • Study Site #2
      • Larissa, Greece
        • CF301-102 Study Site
  • Guatemala
      • Guatemala City, Guatemala
        • CF-301-102 Study Site
      • Santa Rosita, Guatemala
        • CF-301-102 Study Site
  • Israel
      • Be'er Sheva, Israel
        • CF301-102 Study Site
      • Nazareth, Israel
        • CF301-102 Study Site
      • Safed, Israel
        • CF301-102 Study Site
      • Tel HaShomer, Israel
        • CF301-102 Study Site
  • Italy
      • Bergamo, Italy
        • CF301-102 Study Site
      • Busto Arsizio, Italy
        • CF-301-102 Study Site
      • Genoa, Italy
        • CF-301-102 Study Site
  • Russian Federation
      • Krasnodar, Russian Federation
        • CF-301-102 Study Site
      • Moscow, Russian Federation
        • CF-301-102 Study Site
      • St. Pertersburg, Russian Federation
        • CF-301-102 Study Site
      • St. Petersburg, Russian Federation
        • CF-301-102 Study Site #2
  • Spain
      • Barcellona, Spain
        • Cf301-102
      • Barcelona, Spain
        • CF-301-102 Study Site #2
      • Córdoba, Spain
        • CF301-102 Study Site
      • Seville, Spain
        • CF301-102 Study Site
      • Terrassa, Spain
        • CF301-102 Study Site
  • United Kingdom
      • Chelmsford, United Kingdom
        • CF301-102 Study Site
      • Liverpool, United Kingdom
        • CF301-102 Study Site
      • London, United Kingdom
        • CF-301-102 Study Site
      • London, United Kingdom
        • CF301-102 Study Site #2
      • Oxford, United Kingdom
        • CF301-102 Study Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • CF-301-102 Study Site
    • California
      • Sacramento, California, United States, 95817
        • CF-301-102 Study Site
      • Sylmar, California, United States, 91342
        • CF301-102 Study Site
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • CF-301-102 Study Site
    • Delaware
      • Newark, Delaware, United States, 19713
        • CF-301-102 Study Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • CF-301-102 Study Site
      • Augusta, Georgia, United States, 30912
        • CF-301-102 Study Site
      • Decatur, Georgia, United States, 30033
        • CF0301-102 Study Site
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • CF-301 Study Site
    • Illinois
      • Chicago, Illinois, United States, 60637
        • CF301-102 Study Site
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • CF301-102 Study Site
    • Michigan
      • Detroit, Michigan, United States, 48201
        • CF-301-102 Study Site
      • Royal Oak, Michigan, United States, 48073
        • CF301-102 Study Site
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • CF301-102 Study Site
    • Montana
      • Butte, Montana, United States, 59701
        • CF301-102 Study Site
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • CF301-102 Study Site
      • Omaha, Nebraska, United States, 68198
        • CF-301-102 Study Site
    • New Jersey
      • Englewood, New Jersey, United States, 07631
        • CF-301-102 Study Site
      • Paterson, New Jersey, United States, 07102
        • CF301-102 Study Site
    • New York
      • New York, New York, United States, 10029
        • CF-301-102 Study Site
      • New York, New York, United States, 10065
        • CF-301-102 Study Site
      • Valhalla, New York, United States, 10595
        • CF-301-102 Study Site
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • CF-301-102 Study Site
      • Columbus, Ohio, United States, 43210
        • CF301-102 Study Site
      • Columbus, Ohio, United States, 43215
        • Cf-301-102
      • Toledo, Ohio, United States, 43608
        • CF-301 Study Site
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • CF-301-102 Study Site
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Cf-301-102
      • Roanoke, Virginia, United States, 24014
        • CF-301-102 Study Site
    • Washington
      • Seattle, Washington, United States, 98195
        • CF-301-102 Study Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • CF-301-102 Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CF-301
Patients will receive a single IV infusion of CF-301 in addition to standard of care (SOC) antibacterial therapy selected by the investigator.
Biological: CF-301
CF-301, 0.25 mg/kg, given as a single 2 hour iv infusion
Placebo Comparator: Placebo
Patients will receive a single IV infusion of placebo in addition to standard of care (SOC) antibacterial therapy selected by the investigator.
Drug: Placebo
Placebo, given as a single 2 hour iv infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events [Safety and Tolerability]
Time Frame: Through Day 7, at Test of Cure (TOC) between 56-70 days, and at Day 180
Number and percentage of patients with treatment-emergent adverse events (TEAEs)
Through Day 7, at Test of Cure (TOC) between 56-70 days, and at Day 180
Clinical Outcome at Day 14
Time Frame: Day 14
Description of clinical outcome in the Microbiological Intent-to-Treat (mITT) population. Responder (clinical outcome of improvement or response) was defined as survival with improvement or resolution of attributable signs and symptoms, and without new signs or symptoms, new foci of infection, change in antibiotics due to non-response, complications of S. aureus, or further surgery or medical intervention to treat S. aureus.
Day 14
CF-301 Maximum Plasma Concentration (Cmax)
Time Frame: Pre-dose and at 0.5, 1.5, 2, 2.25, 3, 4, 8, 14, 24, and 48 hours after the start of CF-301 infusion
CF-301 plasma concentrations at specified timepoints.
Pre-dose and at 0.5, 1.5, 2, 2.25, 3, 4, 8, 14, 24, and 48 hours after the start of CF-301 infusion
CF-301 Area Under the Curve (AUC 0-t)
Time Frame: Pre-dose and at 0.5, 1.5, 2, 2.25, 3, 4, 8, 14, 24, and 48 hours after the start of CF-301 infusion
CF-301 plasma concentrations at specified time points
Pre-dose and at 0.5, 1.5, 2, 2.25, 3, 4, 8, 14, 24, and 48 hours after the start of CF-301 infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Outcome at Day 7
Time Frame: Day 7
Description of clinical outcome in the mITT population. Responder (clinical outcome of improvement or response) was defined as survival with improvement or resolution of attributable signs and symptoms, and without new signs or symptoms, new foci of infection, change in antibiotics due to non-response, complications of S. aureus, or further surgery or medical intervention to treat S. aureus.
Day 7
Clinical Outcome at End of Standard of Care Antibacterial Therapy (EOT)
Time Frame: EOT between 28-42 days
Description of clinical outcome in the mITT population. Responder (clinical outcome of improvement or response) was defined as survival with improvement or resolution of attributable signs and symptoms, and without new signs or symptoms, new foci of infection, change in antibiotics due to non-response, complications of S. aureus, or further surgery or medical intervention to treat S. aureus.
EOT between 28-42 days
Clinical Outcome at Test of Cure (TOC)
Time Frame: TOC between 56-70 days
Description of clinical outcome in the mITT population. Responder (clinical outcome of improvement or response) was defined as survival with improvement or resolution of attributable signs and symptoms, and without new signs or symptoms, new foci of infection, change in antibiotics due to non-response, complications of S. aureus, or further surgery or medical intervention to treat S. aureus.
TOC between 56-70 days
Clearance of Bacteremia at Day 7 After CF-301/Placebo Administration
Time Frame: Day 7
Number and percentage of patients with clearance of bacteremia in the mITT population
Day 7
Clearance of Bacteremia at Day 14 After CF-301/Placebo Administration
Time Frame: Day 14
Number and percentage of patients with clearance of bacteremia in the mITT population
Day 14
Microbiological Eradication at End of Standard of Care Antibacterial Therapy (EOT)
Time Frame: EOT between 28-42 days
Number and percentage of patients with microbiological eradication in the mITT population
EOT between 28-42 days
Microbiological Eradication at Test of Cure (TOC)
Time Frame: TOC between 56-70 days
Number and percentage of patients with microbiological eradication in the mITT population
TOC between 56-70 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Outcome at Day 14 in MRSA Subgroup
Time Frame: Day 14
Description of clinical outcome in the MRSA subgroup in the mITT population. Responder (clinical outcome of improvement or response) was defined as survival with improvement or resolution of attributable signs and symptoms, and without new signs or symptoms, new foci of infection, change in antibiotics due to non-response, complications of S. aureus, or further surgery or medical intervention to treat S. aureus.
Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ContraFect

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2017

Primary Completion (Actual)

March 7, 2019

Study Completion (Actual)

March 7, 2019

Study Registration Dates

First Submitted

May 15, 2017

First Submitted That Met QC Criteria

May 19, 2017

First Posted (Actual)

May 23, 2017

Study Record Updates

Last Update Posted (Actual)

October 8, 2021

Last Update Submitted That Met QC Criteria

September 10, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CF-301-102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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