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

NCT ID: NCT04597242

Last Updated: 2022-08-31

Basic Information

• Recruitment Status: NO_LONGER_AVAILABLE
• Study Classification: EXPANDED_ACCESS

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.

Conditions

MRSA Bloodstream Infection; MRSA Bacteremia; MRSA Right-sided Endocarditis; Covid19

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ContraFect

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CF-301-107 Study Site

Butte, Montana, United States

Cf 301-107

Toledo, Ohio, United States

Countries

United States

Other Identifiers

CF-301-107

Identifier Type: -

Identifier Source: org_study_id