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)
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
- 发起方
- 试验地点
- 2
研究概览
简要总结
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.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Known or suspected left-sided IE.
- •Intubated for COVID-
- •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.