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Staphylococcus Aureus BacteremiaPhase 3DISRUPTNCT04160468

Direct Lysis of Staph Aureus Resistant Pathogen Trial of Exebacase

A Phase 3 study testing Exebacase in people with Staphylococcus Aureus Bacteremia and Staphylococcus Aureus Endocarditis, run by ContraFect at 55 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 12 years and older
What is being tested?
Exebacase
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
259 participants
Where
55 sitesUnited States
Study dates
20 Dec 2019to 9 Sep 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

55 sites in 1 country.

55 sites in 1 country

United States55 sites

  • Cf 301-105

    Allentown, Pennsylvania, 18103

  • Cf 301-105

    Atlanta, Georgia, 30322

  • Cf 301-105

    Augusta, Georgia, 30912

  • Cf 301-105

    Baltimore, Maryland, 21201

  • Cf 301-105

    Baltimore, Maryland, 21224

  • Cf 301-105

    Birmingham, Alabama, 35294

  • CF 301-105 Study Site

    Boston, Massachusetts, 02215

  • CF-301-105 Study Site

    Burlington, Massachusetts, 01805

  • Cf 301-105

    Burlington, Vermont, 05401

  • CF-301-105 Study Site

    Butte, Montana, 59701

  • Cf 301-105

    Chapel Hill, North Carolina, 27599

  • Cf 301-105

    Charlotte, North Carolina, 28203

  • CF-301-105 Investigator Site

    Chicago, Illinois, 60637

  • CF-301-105 Study Site

    Columbia, Missouri, 65212

  • CF-301-105 Study Site

    Columbus, Ohio, 43210

  • Cf 301-105

    Decatur, Georgia, 30033

  • Cf 301-105

    Detroit, Michigan, 48202

  • Cf 301-105

    Durham, North Carolina, 27710

  • Cf 301-105

    Fort Wayne, Indiana, 46804

  • Cf 301-105

    Gainesville, Florida, 32608

  • Cf 301-105

    Glenview, Illinois, 60026

  • CF-301-105 Study Site

    Greenville, North Carolina, 27834

  • CF-301-105 Study Site

    Hartford, Connecticut, 06102

  • Cf 301-105

    Highland Park, Illinois, 60035

  • Cf 301-105

    Houston, Texas, 77030

  • CF-301-105 Study Site

    Idaho Falls, Idaho, 83404

  • Cf 301-105

    Kansas City, Kansas, 66160

  • Cf 301-105

    Maywood, Illinois, 60153

  • Cf 301-105

    Memphis, Tennessee, 38103

  • Cf 301-105

    Memphis, Tennessee, 38105

  • Cf 301-105

    Milwaukee, Wisconsin, 53226

  • Cf 301-105

    Nashville, Tennessee, 37232

  • Cf 301-105

    Neptune City, New Jersey, 07753

  • Cf 301-105

    New Haven, Connecticut, 06510

  • Cf 301-105

    New York, New York, 10029

  • Cf 301-105

    Newark, New Jersey, 07102

  • Cf 301-105

    Omaha, Nebraska, 68124

  • Cf 301-105

    Omaha, Nebraska, 68198

  • CF-301-105 Study Site

    Orange, California, 92868

  • Cf 301-105

    Philadelphia, Pennsylvania, 19104

  • Cf 301-105

    Philadelphia, Pennsylvania, 19107

  • Cf 301-105

    Rochester, Minnesota, 55905

  • Cf 301-105

    Royal Oak, Michigan, 48073

  • Cf 301-105

    Sacramento, California, 95817

  • CF-301-105 Study Site

    Salt Lake City, Utah, 84108

  • Cf 301-105

    San Diego, California, 92037

  • Cf 301-105

    St Louis, Missouri, 63110

  • CF-301-105 Investigator Site

    Sylmar, California, 91342

  • Cf 301-105

    Toledo, Ohio, 43608

  • Cf 301-105

    Torrance, California, 90502

  • Cf 301-105

    Valhalla, New York, 10595

  • Cf 301-105

    Washington D.C., District of Columbia, 20010

  • Cf 301-105

    Washington D.C., District of Columbia, 20037

  • CF 301-105 Investigator Site

    West Reading, Pennsylvania, 19611

  • Cf 301-105

    Worcester, Massachusetts, 01605

Other trials in United States

About this study

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

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.

Being tested
Exebacase, Placebo
Keywords
S. aureus bloodstream infection, S. aureus bacteremia, S. aureus right-sided infective endocarditis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExebacaseDrug

    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.

  • PlaceboDrug

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

Study groups in NCT04160468
Study groupRoleWhat they receive
ExebacaseExperimentalNot described
Receives: Drug: Exebacase
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day 14

  2. Treatment-emergent Adverse Events (TEAEs) Through Day 60

    Number and percentage of patients with treatment-emergent adverse events (TEAEs)

    Measured: Through Day 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2019
  2. Study start20 Dec 2019
  3. Primary completion9 Sep 2022
  4. Study completion9 Sep 2022

Why it stopped: The independent DSMB recommended that the study be stopped for futility following interim efficacy analysis.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
259 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04160468
Sponsor's protocol ID
CF-301-105
Acronym
DISRUPT
Status last verified
Oct 2023
First submitted
7 Nov 2019
Last updated
2 Nov 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 38297916

  • Traczewski 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.

    PubMed 33910968

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Exebacase in people with Staphylococcus Aureus Bacteremia and Staphylococcus Aureus Endocarditis, run by ContraFect at 55 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Responder Rate at Day 14 in the MRSA Population in the Microbiological Intent-to-treat (mITT) Analysis Set (time frame: Day 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04160468, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2023.

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