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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. Identifier: NCT04160468
Recruitment Status : Recruiting
First Posted : November 13, 2019
Last Update Posted : August 6, 2020
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Staphylococcus Aureus Bacteremia Staphylococcus Aureus Endocarditis Drug: Exebacase Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 348 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of a Single Dose of Exebacase in Patients Receiving Standard-of-Care Antibiotics for the Treatment of Staphylococcus Aureus Bloodstream Infections (Bacteremia), Including Right-Sided Infective Endocarditis
Actual Study Start Date : December 20, 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endocarditis

Arm Intervention/treatment
Experimental: Exebacase 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.

Placebo Comparator: Placebo Drug: Placebo
Participants will receive a single IV infusion of placebo in addition to SoCA selected by the investigator.

Primary Outcome Measures :
  1. Clinical responder rate at Day 14 in the methicillin-resistant Staphylococcus aureus (MRSA) population [ Time Frame: Day 14 ]
  2. Treatment-emergent adverse events (TEAEs) through Day 60 [ Time Frame: Through Day 60 ]
    TEAEs will be summarized by treatment group.

Secondary Outcome Measures :
  1. Clinical responder rate at Day 14 in all S. aureus patients [ Time Frame: Day 14 ]
  2. 30-day survival in the MRSA population [ Time Frame: Through Day 30 ]
  3. Clinical responder rate at Day 60 in the MRSA population [ Time Frame: Day 60 ]
  4. Clinical responder rate at Day 60 in all S. aureus patients [ Time Frame: Day 60 ]
  5. Clinical responder rate at Day 60 in right-sided IE patients (all S. aureus and MRSA populations) [ Time Frame: Day 60 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female, 12 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), and/or known to have COVID-19

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04160468

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Contact: Medical Director, ContraFect 914-207-2300

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United States, Georgia
Cf 301-105 Recruiting
Augusta, Georgia, United States, 30912
United States, Idaho
CF-301-105 Study Site Recruiting
Idaho Falls, Idaho, United States, 83404
United States, Massachusetts
CF-301-105 Study Site Recruiting
Burlington, Massachusetts, United States, 01805
United States, Michigan
Cf 301-105 Recruiting
Detroit, Michigan, United States, 48201
Cf 301-105 Recruiting
Detroit, Michigan, United States, 48202
United States, Missouri
CF-301-105 Study Site Recruiting
Columbia, Missouri, United States, 65201
United States, Montana
CF-301-105 Study Site Recruiting
Butte, Montana, United States, 59701
United States, Nebraska
Cf 301-105 Recruiting
Omaha, Nebraska, United States, 68131
Cf 301-105 Recruiting
Omaha, Nebraska, United States, 68198
United States, New Jersey
CF-301-105 Study Site Recruiting
Englewood, New Jersey, United States, 07631
Cf 301-105 Recruiting
Neptune, New Jersey, United States, 07753
Cf 301-105 Recruiting
Newark, New Jersey, United States, 07102
United States, New York
CF-301-105 Study Site Recruiting
Bronx, New York, United States, 10467
Cf 301-105 Recruiting
New York, New York, United States, 10029
United States, North Carolina
CF-301-105 Study Site Recruiting
Greenville, North Carolina, United States, 27834
United States, Ohio
Cf 301-105 Recruiting
Cleveland, Ohio, United States, 44106
CF-301-105 Study Site Recruiting
Columbus, Ohio, United States, 43210
Cf 301-105 Recruiting
Toledo, Ohio, United States, 43608
United States, Pennsylvania
Cf 301-105 Recruiting
Allentown, Pennsylvania, United States, 18103
Sponsors and Collaborators
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Responsible Party: ContraFect Identifier: NCT04160468    
Other Study ID Numbers: CF-301-105
First Posted: November 13, 2019    Key Record Dates
Last Update Posted: August 6, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ContraFect:
S. aureus bloodstream infection
S. aureus bacteremia
S. aureus right-sided infective endocarditis
Additional relevant MeSH terms:
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Bacterial Infections
Systemic Inflammatory Response Syndrome
Pathologic Processes
Heart Diseases
Cardiovascular Diseases