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Trial record 3 of 4 for:    CF-301

Direct Lysis of Staph Aureus Resistant Pathogen Trial of Exebacase (DISRUPT)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04160468
Recruitment Status : Recruiting
First Posted : November 13, 2019
Last Update Posted : March 26, 2020
Sponsor:
Information provided by (Responsible Party):
ContraFect

Tracking Information
First Submitted Date  ICMJE November 7, 2019
First Posted Date  ICMJE November 13, 2019
Last Update Posted Date March 26, 2020
Actual Study Start Date  ICMJE December 20, 2019
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2019)
  • Clinical responder rate at Day 14 in the methicillin-resistant Staphylococcus aureus (MRSA) population [ Time Frame: Day 14 ]
  • Treatment-emergent adverse events (TEAEs) through Day 60 [ Time Frame: Through Day 60 ]
    TEAEs will be summarized by treatment group.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2019)
  • Clinical responder rate at Day 14 in all S. aureus patients [ Time Frame: Day 14 ]
  • 30-day survival in the MRSA population [ Time Frame: Through Day 30 ]
  • Clinical responder rate at Day 60 in the MRSA population [ Time Frame: Day 60 ]
  • Clinical responder rate at Day 60 in all S. aureus patients [ Time Frame: Day 60 ]
  • Clinical responder rate at Day 60 in right-sided IE patients (all S. aureus and MRSA populations) [ Time Frame: Day 60 ]
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 Direct Lysis of Staph Aureus Resistant Pathogen Trial of Exebacase
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of a Single Dose of Exebacase in Adult Patients Receiving Standard-of-Care Antibiotics for the Treatment of Staphylococcus Aureus Bloodstream Infections (Bacteremia), Including Right-Sided Infective Endocarditis
Brief Summary

The purpose of this superiority study is to evaluate the efficacy and safety of exebacase in addition to standard of care antibiotics (SoCA) compared with SoCA alone for the treatment of patients with Staphylococcus aureus (S. aureus) bloodstream infections (BSI), including right-sided infective endocarditis (IE). Patients will be randomized to receive a single intravenous dose of exebacase or placebo. Patients will receive SoCA selected by the investigators based on the protocol.

Exebacase, a direct lytic agent, is an entirely new treatment modality against S. aureus. Exebacase is a recombinantly-produced, purified cell wall hydrolase enzyme that results in rapid bacteriolysis, potent biofilm eradication, synergy with antibiotics, low propensity for resistance, and the potential to suppress antibiotic resistance when used together with antibiotics. Exebacase represents a first-in-field, first-in-class treatment with the potential to improve clinical outcome when used in addition to SoCA to treat S. aureus BSI including IE.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
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
  • Drug: Exebacase
    Participants will receive a single IV infusion of exebacase in addition to SoCA selected by the investigator. Participants with normal renal function or mild renal impairment will be administered a dose of 18 mg; participants with moderate or severe renal impairment will be administered a dose of 12 mg of exebacase; participants with end-stage renal disease, including those on hemodialysis, will be administered a dose of 8 mg of exebacase.
  • Drug: Placebo
    Participants will receive a single IV infusion of placebo in addition to SoCA selected by the investigator.
Study Arms  ICMJE
  • Experimental: Exebacase
    Intervention: Drug: Exebacase
  • Placebo Comparator: Placebo
    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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 8, 2019)
348
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2021
Estimated Primary Completion Date August 2021   (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 two signs or symptoms attributable to S. aureus BSI/IE
  • Known or suspected complicated S. aureus BSI and/or right-sided IE based on Modified Duke Criteria
  • Not pregnant or breastfeeding and not of reproductive potential or agrees to remain abstinent or use contraception if of reproductive potential

Exclusion Criteria:

  • Previously received exebacase
  • Known or suspected left-sided IE
  • Treatment with effective systemic anti-staphylococcal antibiotic for more than 72 hours within 7 days before randomization
  • Presence of prosthetic valve or cardiac valve support ring, or presence of known or suspected infected orthopedic hardware, prosthetic joint, or cardiac device
  • Known or suspected brain abscess or meningitis
  • Known or suspected urinary tract infection or primary pneumonia as the sole source of S. aureus BSI
  • Known polymicrobial BSI, or known ongoing systemic infection caused by other bacterial and/or fungal pathogen(s)
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: Medical Director, ContraFect 914-207-2300 clinicalstudies@contrafect.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04160468
Other Study ID Numbers  ICMJE CF-301-105
Has Data Monitoring Committee Yes
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 March 2020

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