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Trial record 1 of 4 for:    CF-301
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Safety, Efficacy and Pharmacokinetics of CF-301 vs. Placebo in Addition to Antibacterial Therapy for Treatment of S. Aureus Bacteremia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03163446
Recruitment Status : Completed
First Posted : May 23, 2017
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
ContraFect

Tracking Information
First Submitted Date  ICMJE May 15, 2017
First Posted Date  ICMJE May 23, 2017
Last Update Posted Date May 20, 2019
Actual Study Start Date  ICMJE May 23, 2017
Actual Primary Completion Date March 7, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 19, 2017)
  • Incidence of adverse events [Safety and Tolerability] [ Time Frame: Up to 28 days and up to 180 days ]
    Description of incidence of adverse events
  • Clinical outcome at Day 14 (improvement, response, non-response) [ Time Frame: Day 14 ]
    Description of clinical outcome in the microbiological Intent-to-Treat (mITT) population
  • CF-301 Maximum plasma concentration (Cmax) and time to Cmax [ Time Frame: Up to 48 hours ]
    CF-301 plasma concentrations at various time points
  • CF-301 time to clearance [ Time Frame: Up to 48 hours ]
    CF-301 plasma concentrations at various time points
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2017)
  • Clinical outcome at Day 7 (improvement, response, non-response) [ Time Frame: Day 7 ]
    Description of clinical outcome in the mITT population
  • Clinical outcome at End of Standard of Care Therapy (EOT) (response, non-response) [ Time Frame: Between 28-42 days ]
    Description of clinical outcome in the mITT population
  • Clinical outcome at Test of Cure (TOC) (response, non-response) [ Time Frame: Between 56-70 days ]
    Description of clinical outcome in the mITT population
  • 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
  • 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
  • Microbiological eradication at end of standard-of-care antibacterial therapy (EOT) [ Time Frame: Between 28-42 days ]
    Number and percentage of patients with microbiological eradication in the mITT population
  • Microbiological eradication at test of cure (TOC) [ Time Frame: Between 56-70 days ]
    Number and percentage of patients with microbiological eradication in the mITT population
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Efficacy and Pharmacokinetics of CF-301 vs. Placebo in Addition to Antibacterial Therapy for Treatment of S. Aureus Bacteremia
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Staphylococcus Aureus Bacteremia
  • Staphylococcus Aureus Endocarditis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Biological: CF-301
  • 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.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 16, 2019)
121
Original Estimated Enrollment  ICMJE
 (submitted: May 19, 2017)
115
Actual Study Completion Date  ICMJE March 7, 2019
Actual Primary Completion Date March 7, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Bulgaria,   Chile,   Czechia,   France,   Germany,   Greece,   Guatemala,   Israel,   Italy,   Russian Federation,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03163446
Other Study ID Numbers  ICMJE CF-301-102
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ContraFect
Study Sponsor  ICMJE ContraFect
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account ContraFect
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP