Study Stopped
The independent DSMB recommended that the study be stopped for futility following interim efficacy analysis.
Direct Lysis of Staph Aureus Resistant Pathogen Trial of Exebacase
DISRUPT
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
1 other identifier
interventional
259
1 country
55
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2019
Typical duration for phase_3
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 7, 2019
CompletedFirst Posted
Study publicly available on registry
November 13, 2019
CompletedStudy Start
First participant enrolled
December 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 9, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 9, 2022
CompletedResults Posted
Study results publicly available
October 18, 2023
CompletedNovember 2, 2023
October 1, 2023
2.7 years
November 7, 2019
September 23, 2023
October 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Clinical Responder Rate at Day 14 in the MRSA Population in the Microbiological Intent-to-treat (mITT) Analysis Set
Clinical outcome of responder was defined as survival with resolution or 2-grade improvement of attributable signs and symptoms and negative blood cultures by Day 14, and without new signs or symptoms, new metastatic foci or septic emboli, or change in antibiotics due to lack of response.
Day 14
Treatment-emergent Adverse Events (TEAEs) Through Day 60
Number and percentage of patients with treatment-emergent adverse events (TEAEs)
Through Day 60
Study Arms (2)
Exebacase
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
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.
Participants will receive a single IV infusion of placebo in addition to SoCA selected by the investigator.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 hardware (orthopedic), prosthetic joint, or cardiac device
- Known polymicrobial BSI, or known ongoing systemic infection caused by other bacterial and/or fungal pathogen(s), and/or known to have coronavirus disease 2019 (COVID-19)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ContraFectlead
Study Sites (55)
Cf 301-105
Birmingham, Alabama, 35294, United States
CF-301-105 Study Site
Orange, California, 92868, United States
Cf 301-105
Sacramento, California, 95817, United States
Cf 301-105
San Diego, California, 92037, United States
CF-301-105 Investigator Site
Sylmar, California, 91342, United States
Cf 301-105
Torrance, California, 90502, United States
CF-301-105 Study Site
Hartford, Connecticut, 06102, United States
Cf 301-105
New Haven, Connecticut, 06510, United States
Cf 301-105
Washington D.C., District of Columbia, 20010, United States
Cf 301-105
Washington D.C., District of Columbia, 20037, United States
Cf 301-105
Gainesville, Florida, 32608, United States
Cf 301-105
Atlanta, Georgia, 30322, United States
Cf 301-105
Augusta, Georgia, 30912, United States
Cf 301-105
Decatur, Georgia, 30033, United States
CF-301-105 Study Site
Idaho Falls, Idaho, 83404, United States
CF-301-105 Investigator Site
Chicago, Illinois, 60637, United States
Cf 301-105
Glenview, Illinois, 60026, United States
Cf 301-105
Highland Park, Illinois, 60035, United States
Cf 301-105
Maywood, Illinois, 60153, United States
Cf 301-105
Fort Wayne, Indiana, 46804, United States
Cf 301-105
Kansas City, Kansas, 66160, United States
Cf 301-105
Baltimore, Maryland, 21201, United States
Cf 301-105
Baltimore, Maryland, 21224, United States
CF 301-105 Study Site
Boston, Massachusetts, 02215, United States
CF-301-105 Study Site
Burlington, Massachusetts, 01805, United States
Cf 301-105
Worcester, Massachusetts, 01605, United States
Cf 301-105
Detroit, Michigan, 48202, United States
Cf 301-105
Royal Oak, Michigan, 48073, United States
Cf 301-105
Rochester, Minnesota, 55905, United States
CF-301-105 Study Site
Columbia, Missouri, 65212, United States
Cf 301-105
St Louis, Missouri, 63110, United States
CF-301-105 Study Site
Butte, Montana, 59701, United States
Cf 301-105
Omaha, Nebraska, 68124, United States
Cf 301-105
Omaha, Nebraska, 68198, United States
Cf 301-105
Neptune City, New Jersey, 07753, United States
Cf 301-105
Newark, New Jersey, 07102, United States
Cf 301-105
New York, New York, 10029, United States
Cf 301-105
Valhalla, New York, 10595, United States
Cf 301-105
Chapel Hill, North Carolina, 27599, United States
Cf 301-105
Charlotte, North Carolina, 28203, United States
Cf 301-105
Durham, North Carolina, 27710, United States
CF-301-105 Study Site
Greenville, North Carolina, 27834, United States
CF-301-105 Study Site
Columbus, Ohio, 43210, United States
Cf 301-105
Toledo, Ohio, 43608, United States
Cf 301-105
Allentown, Pennsylvania, 18103, United States
Cf 301-105
Philadelphia, Pennsylvania, 19104, United States
Cf 301-105
Philadelphia, Pennsylvania, 19107, United States
CF 301-105 Investigator Site
West Reading, Pennsylvania, 19611, United States
Cf 301-105
Memphis, Tennessee, 38103, United States
Cf 301-105
Memphis, Tennessee, 38105, United States
Cf 301-105
Nashville, Tennessee, 37232, United States
Cf 301-105
Houston, Texas, 77030, United States
CF-301-105 Study Site
Salt Lake City, Utah, 84108, United States
Cf 301-105
Burlington, Vermont, 05401, United States
Cf 301-105
Milwaukee, Wisconsin, 53226, United States
Related Publications (2)
Fowler VG Jr, Das AF, Lipka-Diamond J, Ambler JE, Schuch R, Pomerantz R, Cassino C, Jauregui-Peredo L, Moran GJ, Rupp ME, Lachiewicz AM, Kuti JL, Wise RA, Kaye KS, Zervos MJ, Nichols WG. Exebacase in Addition to Standard-of-Care Antibiotics for Staphylococcus aureus Bloodstream Infections and Right-Sided Infective Endocarditis: A Phase 3, Superiority-Design, Placebo-Controlled, Randomized Clinical Trial (DISRUPT). Clin Infect Dis. 2024 Jun 14;78(6):1473-1481. doi: 10.1093/cid/ciae043.
PMID: 38297916DERIVEDTraczewski MM, Ambler JE, Schuch R. Determination of MIC Quality Control Parameters for Exebacase, a Novel Lysin with Antistaphylococcal Activity. J Clin Microbiol. 2021 Jun 18;59(7):e0311720. doi: 10.1128/JCM.03117-20. Epub 2021 Jun 18.
PMID: 33910968DERIVED
MeSH Terms
Interventions
Results Point of Contact
- Title
- Medical Director
- Organization
- ContraFect
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2019
First Posted
November 13, 2019
Study Start
December 20, 2019
Primary Completion
September 9, 2022
Study Completion
September 9, 2022
Last Updated
November 2, 2023
Results First Posted
October 18, 2023
Record last verified: 2023-10