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 : September 4, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||348 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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||
Participants will receive a single IV infusion of placebo in addition to SoCA selected by the investigator.
- 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.
- 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 ]
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
|Contact: Medical Director, ContraFectemail@example.com|