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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
121

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 23, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 7, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 7, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 15, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 23, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 8, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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