Direct Lysis of Staph Aureus Resistant Pathogen Trial of Exebacase (DISRUPT)
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| ClinicalTrials.gov Identifier: NCT04160468 |
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Recruitment Status :
Terminated
(The independent DSMB recommended that the study be stopped for futility following interim efficacy analysis.)
First Posted : November 13, 2019
Last Update Posted : January 19, 2023
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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) |
| Actual Enrollment : | 259 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 |
| Actual Primary Completion Date : | July 13, 2022 |
| Actual Study Completion Date : | September 9, 2022 |
| 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. |
- 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 ]
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.
| 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 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 COVID-19
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
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| Responsible Party: | ContraFect |
| ClinicalTrials.gov Identifier: | NCT04160468 |
| Other Study ID Numbers: |
CF-301-105 |
| First Posted: | November 13, 2019 Key Record Dates |
| Last Update Posted: | January 19, 2023 |
| Last Verified: | September 2022 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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S. aureus bloodstream infection S. aureus bacteremia S. aureus right-sided infective endocarditis |
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Staphylococcal Infections Bacteremia Endocarditis Gram-Positive Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Infections |
Sepsis Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Heart Diseases Cardiovascular Diseases |