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Trial record 3 of 4 for:    CF-301

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

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ClinicalTrials.gov Identifier: NCT04160468
Recruitment Status : Not yet recruiting
First Posted : November 13, 2019
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
ContraFect

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 Adult Patients Receiving Standard-of-Care Antibiotics for the Treatment of Staphylococcus Aureus Bloodstream Infections (Bacteremia), Including Right-Sided Infective Endocarditis
Estimated Study Start Date : December 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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

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 ClinicalTrials.gov identifier (NCT number): NCT04160468


Contacts
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Contact: Medical Director, ContraFect 914-207-2300 clinicalstudies@contrafect.com

Sponsors and Collaborators
ContraFect

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Responsible Party: ContraFect
ClinicalTrials.gov Identifier: NCT04160468     History of Changes
Other Study ID Numbers: CF-301-105
First Posted: November 13, 2019    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019

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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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Bacteremia
Endocarditis
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Heart Diseases
Cardiovascular Diseases