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Expanded Access Study of Exebacase in COVID-19 Patients With Persistent MRSA Bacteremia

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ClinicalTrials.gov Identifier: NCT04597242
Expanded Access Status : Temporarily not available
First Posted : October 22, 2020
Last Update Posted : September 10, 2021
Sponsor:
Information provided by (Responsible Party):
ContraFect

Study Description
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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.


Condition or disease Intervention/treatment
MRSA Bloodstream Infection MRSA Bacteremia MRSA Right-sided Endocarditis Covid19 Drug: Exebacase

Study Design
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Study Type : Expanded Access
Expanded Access Type : Intermediate-size Population
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)

Resource links provided by the National Library of Medicine


Interventions
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Intervention Details:
  • Drug: Exebacase
    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.
Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Contacts and Locations
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Information from the National Library of Medicine

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): NCT04597242


Locations
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United States, Montana
CF-301-107 Study Site
Butte, Montana, United States, 59701
United States, Ohio
Cf 301-107
Toledo, Ohio, United States, 43608
Sponsors and Collaborators
ContraFect
More Information
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Responsible Party: ContraFect
ClinicalTrials.gov Identifier: NCT04597242    
Other Study ID Numbers: CF-301-107
First Posted: October 22, 2020    Key Record Dates
Last Update Posted: September 10, 2021
Last Verified: September 2021
Additional relevant MeSH terms:
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Infections
COVID-19
Bacteremia
Sepsis
Endocarditis
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Bacterial Infections
Bacterial Infections and Mycoses
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Heart Diseases
Cardiovascular Diseases