NCT04597242

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

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)

• Status: No Longer Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: ContraFect · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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

Type	Name	Description
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.

Timeline

• First posted: 2020-10-22
• Last updated: 2022-08-31

Locations

2 sites across 1 country: United States