search
Back to results

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

Primary Purpose

Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Endocarditis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CF-301
Placebo
Sponsored by
ContraFect
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Staphylococcus Aureus Bacteremia focused on measuring Staphylococcus aureus, bacteremia, staphylococcal endocarditis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CF-301-102 Study Site
  • CF-301-102 Study Site
  • CF301-102 Study Site
  • CF-301-102 Study Site
  • CF-301-102 Study Site
  • CF-301-102 Study Site
  • CF-301-102 Study Site
  • CF0301-102 Study Site
  • CF-301 Study Site
  • CF301-102 Study Site
  • CF301-102 Study Site
  • CF-301-102 Study Site
  • CF301-102 Study Site
  • CF301-102 Study Site
  • CF301-102 Study site
  • CF301-102 Study Site
  • CF-301-102 Study Site
  • CF-301-102 Study Site
  • CF301-102 Study Site
  • CF-301-102 Study Site
  • CF-301-102 Study Site
  • CF-301-102 Study Site
  • CF-301-102 Study Site
  • CF301-102 Study Site
  • Cf-301-102
  • CF-301 Study Site
  • CF-301-102 Study Site
  • Cf-301-102
  • CF-301-102 Study Site
  • CF-301-102 Study Site
  • CF-301-102 Study Site
  • CF-301-102 Study Site #2
  • CF301-102 Study Site
  • CF301-102 Study Site
  • CF301-102 Study Site
  • CF301-102 Study Site
  • CF301-102 Study Site
  • CF301-102 Study Site
  • CF-301-102 Study Site
  • CF-301-102 Study Site
  • CF301-102 Study Site
  • CF301-102 Study Site #2
  • CF301-102 Study Site
  • CF301-102 Study Site
  • CF301-102 Study Site
  • CF301-102 Study Site
  • CF301-102 Study Site
  • CF-301-102 Study Site #2
  • CF-301-102 Study Site
  • CF-301-102 Study Site
  • CF-301-102 Study Site
  • CF301-102 Study Site #3
  • CF301-102 Study Site
  • Study Site #2
  • CF301-102 Study Site
  • CF-301-102 Study Site
  • CF-301-102 Study Site
  • CF301-102 Study Site
  • CF301-102 Study Site
  • CF301-102 Study Site
  • CF301-102 Study Site
  • CF301-102 Study Site
  • CF-301-102 Study Site
  • CF-301-102 Study Site
  • CF-301-102 Study Site
  • CF-301-102 Study Site
  • CF-301-102 Study Site
  • CF-301-102 Study Site #2
  • Cf301-102
  • CF-301-102 Study Site #2
  • CF301-102 Study Site
  • CF301-102 Study Site
  • CF301-102 Study Site
  • CF301-102 Study Site
  • CF301-102 Study Site
  • CF-301-102 Study Site
  • CF301-102 Study Site #2
  • CF301-102 Study Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CF-301

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Incidence of Adverse Events [Safety and Tolerability]
Number and percentage of patients with treatment-emergent adverse events (TEAEs)
Clinical Outcome at 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.
CF-301 Maximum Plasma Concentration (Cmax)
CF-301 plasma concentrations at specified timepoints.
CF-301 Area Under the Curve (AUC 0-t)
CF-301 plasma concentrations at specified time points

Secondary Outcome Measures

Clinical Outcome at 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.
Clinical Outcome at End of Standard of Care Antibacterial Therapy (EOT)
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.
Clinical Outcome at Test of Cure (TOC)
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.
Clearance of Bacteremia at Day 7 After CF-301/Placebo Administration
Number and percentage of patients with clearance of bacteremia in the mITT population
Clearance of Bacteremia at Day 14 After CF-301/Placebo Administration
Number and percentage of patients with clearance of bacteremia in the mITT population
Microbiological Eradication at End of Standard of Care Antibacterial Therapy (EOT)
Number and percentage of patients with microbiological eradication in the mITT population
Microbiological Eradication at Test of Cure (TOC)
Number and percentage of patients with microbiological eradication in the mITT population

Full Information

First Posted
May 15, 2017
Last Updated
September 10, 2021
Sponsor
ContraFect
search

1. Study Identification

Unique Protocol Identification Number
NCT03163446
Brief Title
Safety, Efficacy and Pharmacokinetics of CF-301 vs. Placebo in Addition to Antibacterial Therapy for Treatment of S. Aureus Bacteremia
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
May 23, 2017 (Actual)
Primary Completion Date
March 7, 2019 (Actual)
Study Completion Date
March 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ContraFect

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Endocarditis
Keywords
Staphylococcus aureus, bacteremia, staphylococcal endocarditis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CF-301
Arm Type
Experimental
Arm Description
Patients will receive a single IV infusion of CF-301 in addition to standard of care (SOC) antibacterial therapy selected by the investigator.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will receive a single IV infusion of placebo in addition to standard of care (SOC) antibacterial therapy selected by the investigator.
Intervention Type
Biological
Intervention Name(s)
CF-301
Intervention Description
CF-301, 0.25 mg/kg, given as a single 2 hour iv infusion
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, given as a single 2 hour iv infusion
Primary Outcome Measure Information:
Title
Incidence of Adverse Events [Safety and Tolerability]
Description
Number and percentage of patients with treatment-emergent adverse events (TEAEs)
Time Frame
Through Day 7, at Test of Cure (TOC) between 56-70 days, and at Day 180
Title
Clinical Outcome at Day 14
Description
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.
Time Frame
Day 14
Title
CF-301 Maximum Plasma Concentration (Cmax)
Description
CF-301 plasma concentrations at specified timepoints.
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
Title
CF-301 Area Under the Curve (AUC 0-t)
Description
CF-301 plasma concentrations at specified time points
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
Secondary Outcome Measure Information:
Title
Clinical Outcome at Day 7
Description
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.
Time Frame
Day 7
Title
Clinical Outcome at End of Standard of Care Antibacterial Therapy (EOT)
Description
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.
Time Frame
EOT between 28-42 days
Title
Clinical Outcome at Test of Cure (TOC)
Description
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.
Time Frame
TOC between 56-70 days
Title
Clearance of Bacteremia at Day 7 After CF-301/Placebo Administration
Description
Number and percentage of patients with clearance of bacteremia in the mITT population
Time Frame
Day 7
Title
Clearance of Bacteremia at Day 14 After CF-301/Placebo Administration
Description
Number and percentage of patients with clearance of bacteremia in the mITT population
Time Frame
Day 14
Title
Microbiological Eradication at End of Standard of Care Antibacterial Therapy (EOT)
Description
Number and percentage of patients with microbiological eradication in the mITT population
Time Frame
EOT between 28-42 days
Title
Microbiological Eradication at Test of Cure (TOC)
Description
Number and percentage of patients with microbiological eradication in the mITT population
Time Frame
TOC between 56-70 days
Other Pre-specified Outcome Measures:
Title
Clinical Outcome at Day 14 in MRSA Subgroup
Description
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.
Time Frame
Day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CF-301-102 Study Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
CF-301-102 Study Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
CF301-102 Study Site
City
Sylmar
State/Province
California
ZIP/Postal Code
91342
Country
United States
Facility Name
CF-301-102 Study Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
CF-301-102 Study Site
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
CF-301-102 Study Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
CF-301-102 Study Site
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
CF0301-102 Study Site
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
CF-301 Study Site
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
CF301-102 Study Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
CF301-102 Study Site
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
CF-301-102 Study Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
CF301-102 Study Site
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
CF301-102 Study Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
CF301-102 Study site
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
CF301-102 Study Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
CF-301-102 Study Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
CF-301-102 Study Site
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Facility Name
CF301-102 Study Site
City
Paterson
State/Province
New Jersey
ZIP/Postal Code
07102
Country
United States
Facility Name
CF-301-102 Study Site
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
CF-301-102 Study Site
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
CF-301-102 Study Site
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
CF-301-102 Study Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
CF301-102 Study Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Cf-301-102
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
CF-301 Study Site
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States
Facility Name
CF-301-102 Study Site
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Cf-301-102
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
CF-301-102 Study Site
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
CF-301-102 Study Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
CF-301-102 Study Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
CF-301-102 Study Site #2
City
Brussels
Country
Belgium
Facility Name
CF301-102 Study Site
City
Brussels
Country
Belgium
Facility Name
CF301-102 Study Site
City
Edegem
Country
Belgium
Facility Name
CF301-102 Study Site
City
Ghent
Country
Belgium
Facility Name
CF301-102 Study Site
City
Leuven
Country
Belgium
Facility Name
CF301-102 Study Site
City
Ruse
Country
Bulgaria
Facility Name
CF301-102 Study Site
City
Sofia
Country
Bulgaria
Facility Name
CF-301-102 Study Site
City
Santiago
Country
Chile
Facility Name
CF-301-102 Study Site
City
Viña Del Mar
Country
Chile
Facility Name
CF301-102 Study Site
City
Brno
Country
Czechia
Facility Name
CF301-102 Study Site #2
City
Prague
Country
Czechia
Facility Name
CF301-102 Study Site
City
Prague
Country
Czechia
Facility Name
CF301-102 Study Site
City
Limoges
Country
France
Facility Name
CF301-102 Study Site
City
Lyon
Country
France
Facility Name
CF301-102 Study Site
City
Paris
Country
France
Facility Name
CF301-102 Study Site
City
Toulon
Country
France
Facility Name
CF-301-102 Study Site #2
City
Berlin
Country
Germany
Facility Name
CF-301-102 Study Site
City
Berlin
Country
Germany
Facility Name
CF-301-102 Study Site
City
Cologne
Country
Germany
Facility Name
CF-301-102 Study Site
City
Freiburg
Country
Germany
Facility Name
CF301-102 Study Site #3
City
Athens
Country
Greece
Facility Name
CF301-102 Study Site
City
Athens
Country
Greece
Facility Name
Study Site #2
City
Athens
Country
Greece
Facility Name
CF301-102 Study Site
City
Larissa
Country
Greece
Facility Name
CF-301-102 Study Site
City
Guatemala City
Country
Guatemala
Facility Name
CF-301-102 Study Site
City
Santa Rosita
Country
Guatemala
Facility Name
CF301-102 Study Site
City
Be'er Sheva
Country
Israel
Facility Name
CF301-102 Study Site
City
Nazareth
Country
Israel
Facility Name
CF301-102 Study Site
City
Safed
Country
Israel
Facility Name
CF301-102 Study Site
City
Tel HaShomer
Country
Israel
Facility Name
CF301-102 Study Site
City
Bergamo
Country
Italy
Facility Name
CF-301-102 Study Site
City
Busto Arsizio
Country
Italy
Facility Name
CF-301-102 Study Site
City
Genoa
Country
Italy
Facility Name
CF-301-102 Study Site
City
Krasnodar
Country
Russian Federation
Facility Name
CF-301-102 Study Site
City
Moscow
Country
Russian Federation
Facility Name
CF-301-102 Study Site
City
St. Pertersburg
Country
Russian Federation
Facility Name
CF-301-102 Study Site #2
City
St. Petersburg
Country
Russian Federation
Facility Name
Cf301-102
City
Barcellona
Country
Spain
Facility Name
CF-301-102 Study Site #2
City
Barcelona
Country
Spain
Facility Name
CF301-102 Study Site
City
Córdoba
Country
Spain
Facility Name
CF301-102 Study Site
City
Seville
Country
Spain
Facility Name
CF301-102 Study Site
City
Terrassa
Country
Spain
Facility Name
CF301-102 Study Site
City
Chelmsford
Country
United Kingdom
Facility Name
CF301-102 Study Site
City
Liverpool
Country
United Kingdom
Facility Name
CF-301-102 Study Site
City
London
Country
United Kingdom
Facility Name
CF301-102 Study Site #2
City
London
Country
United Kingdom
Facility Name
CF301-102 Study Site
City
Oxford
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
32271718
Citation
Fowler VG Jr, Das AF, Lipka-Diamond J, Schuch R, Pomerantz R, Jauregui-Peredo L, Bressler A, Evans D, Moran GJ, Rupp ME, Wise R, Corey GR, Zervos M, Douglas PS, Cassino C. Exebacase for patients with Staphylococcus aureus bloodstream infection and endocarditis. J Clin Invest. 2020 Jul 1;130(7):3750-3760. doi: 10.1172/JCI136577.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs