Expanded Access Study of Exebacase in COVID-19 Patients With Persistent MRSA Bacteremia
Primary Purpose
MRSA Bloodstream Infection, MRSA Bacteremia, MRSA Right-sided Endocarditis
Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Exebacase
Sponsored by
About this trial
This is an expanded access trial for MRSA Bloodstream Infection
Eligibility Criteria
Inclusion Criteria:
- Male or female, 18 years of age or older.
- Hospitalized with known COVID-19 infection confirmed by positive diagnostic test.
- Not eligible for the exebacase Phase 3 study (CF-301-105).
- Blood cultures positive for MRSA for ≥3 days.
- Patient is not pregnant or breastfeeding and is not of reproductive potential or agrees to remain abstinent or use contraception if of reproductive potential.
Exclusion Criteria:
- Known or suspected left-sided IE.
- Intubated for COVID-19.
- Presence of prosthetic valve or cardiac valve support ring, or presence of known infected orthopedic hardware, prosthetic joint, or cardiac device.
- Known or suspected brain abscess or meningitis.
- Participation in an investigational study or expanded access protocol for another antistaphylococcal antibacterial agent.
Sites / Locations
- CF-301-107 Study Site
- Cf 301-107
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04597242
Brief Title
Expanded Access Study of Exebacase in COVID-19 Patients With Persistent MRSA Bacteremia
Official Title
Expanded Access Study of a Single Dose of Exebacase in Addition to Antistaphylococcal Antibiotics for the Treatment of Persistent Methicillin-Resistant Staphylococcus Aureus (MRSA) Bloodstream Infections (Including Right Sided Endocarditis) in Patients Who Are Hospitalized With Coronavirus Disease 2019 (COVID-19)
Study Type
Expanded Access
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
No longer available
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ContraFect
4. Oversight
5. Study Description
Brief Summary
This is an open-label, expanded access study of exebacase used in addition to antistaphylococcal antibiotics in adult patients with persistent methicillin-resistant Staphylococcus aureus (MRSA) bloodstream infections (BSI), including right-sided endocarditis (R-IE), who are hospitalized with coronavirus disease 2019 (COVID-19). Patients with left-sided endocarditis (L-IE) are excluded. Patients will receive a single dose of exebacase. Patients will continue to receive antistaphylococcal antibiotics as prescribed by the treating physician. Exebacase Phase 3 study sites (Study CF-301-105) may participate in this Expanded Access study (Study CF-301-107).
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 standard-of-care antibiotics to treat S. aureus BSI including IE.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
MRSA Bloodstream Infection, MRSA Bacteremia, MRSA Right-sided Endocarditis, Covid19
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Exebacase
Intervention Description
Patients will receive a single IV infusion of exebacase in addition to antistaphylococcal antibiotics prescribed by the treating physician. Patients with normal renal function or mild renal impairment will be administered a dose of 18 mg of exebacase; patients with moderate or severe renal impairment will be administered a dose of 12 mg; patients with end-stage renal disease, including those on hemodialysis, will be administered a dose of 8 mg.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria:
Male or female, 18 years of age or older.
Hospitalized with known COVID-19 infection confirmed by positive diagnostic test.
Not eligible for the exebacase Phase 3 study (CF-301-105).
Blood cultures positive for MRSA for ≥3 days.
Patient is not pregnant or breastfeeding and is not of reproductive potential or agrees to remain abstinent or use contraception if of reproductive potential.
Exclusion Criteria:
Known or suspected left-sided IE.
Intubated for COVID-19.
Presence of prosthetic valve or cardiac valve support ring, or presence of known infected orthopedic hardware, prosthetic joint, or cardiac device.
Known or suspected brain abscess or meningitis.
Participation in an investigational study or expanded access protocol for another antistaphylococcal antibacterial agent.
Facility Information:
Facility Name
CF-301-107 Study Site
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Cf 301-107
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Expanded Access Study of Exebacase in COVID-19 Patients With Persistent MRSA Bacteremia
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