A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of a Single Dose of Exebacase in Patients Receiving Standard-of-Care Antibiotics for the Treatment of Staphylococcus Aureus Bloodstream Infections (Bacteremia), Including Right-Sided Infective Endocarditis
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 259
- 试验地点
- 5
- 主要终点
- Treatment-emergent Adverse Events (TEAEs) Through Day 60
研究概览
简要总结
The purpose of this superiority study is to evaluate the efficacy and safety of exebacase in addition to standard of care antibiotics (SoCA) compared with SoCA alone for the treatment of patients with Staphylococcus aureus (S. aureus) bloodstream infections (BSI), including right-sided infective endocarditis (IE). Patients will be randomized to receive a single intravenous dose of exebacase or placebo. Patients will receive SoCA selected by the investigators based on the protocol.
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 SoCA to treat S. aureus BSI including IE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 12 years or older
- •Blood culture positive for S. aureus
- •At least two signs or symptoms attributable to S. aureus BSI/IE
- •Known or suspected complicated S. aureus BSI and/or right-sided IE based on Modified Duke Criteria
- •Not pregnant or breastfeeding and not of reproductive potential or agrees to remain abstinent or use contraception if of reproductive potential
排除标准
- •Previously received exebacase
- •Known or suspected left-sided IE
- •Treatment with effective systemic anti-staphylococcal antibiotic for more than 72 hours within 7 days before randomization
- •Presence of prosthetic valve or cardiac valve support ring, or presence of known or suspected infected hardware (orthopedic), prosthetic joint, or cardiac device
- •Known polymicrobial BSI, or known ongoing systemic infection caused by other bacterial and/or fungal pathogen(s), and/or known to have coronavirus disease 2019 (COVID-19)
研究组 & 干预措施
Exebacase
干预措施: Exebacase (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Treatment-emergent Adverse Events (TEAEs) Through Day 60
时间窗: Through Day 60
Number and percentage of patients with treatment-emergent adverse events (TEAEs)
Clinical Responder Rate at Day 14 in the MRSA Population in the Microbiological Intent-to-treat (mITT) Analysis Set
时间窗: Day 14
Clinical outcome of responder was defined as survival with resolution or 2-grade improvement of attributable signs and symptoms and negative blood cultures by Day 14, and without new signs or symptoms, new metastatic foci or septic emboli, or change in antibiotics due to lack of response.
次要结局
未报告次要终点