A Multicenter, Double-Blind, Randomized, Comparative Study of the Safety, Tolerability, Efficacy, and Pharmacokinetics of CF-301 vs. Placebo in Addition to Standard-of-Care Antibacterial Therapy for the Treatment of Adult Patients With Staphylococcus Aureus Bloodstream Infections (Bacteremia) Including Endocarditis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 试验地点
- 11
- 主要终点
- Clinical Outcome at Day 14
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, efficacy and pharmacokinetics (PK) of CF-301 in addition to background standard of care (SOC) antibacterial therapy for the treatment of Staphylococcus aureus (S. aureus) bloodstream infections (bacteremia), including endocarditis in adults. Patients will be randomized to receive a single intravenous dose of CF-301 or placebo in addition to SOC antibacterial therapy. Patients will be prescribed standard of care antibiotics selected by the investigators based on their professional experience, practice guidelines and local antibiotic susceptibility information for the treatment of S. aureus bacteremia.
CF-301 is a lysin and member of a new class of targeted protein-based antimicrobials that has demonstrated activity against S. aureus in laboratory (in vitro) and animal studies, alone and in addition to conventional antibiotics.
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
- 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 or older
- •blood culture positive for S. aureus
- •at least one sign or symptom attributable to S. aureus bacteremia
- •known or suspected complicated S. aureus BSI and/or endocarditis by Modified Duke Criteria
- •patient is not pregnant or breastfeeding and is not of reproductive potential or agrees to use contraception if of reproductive potential.
排除标准
- •patient previously received CF-
- •treatment with any potentially effective (anti-staphylococcal) systemic antibiotic for more than 72 hours within 7 days before randomization.
- •presence of any removable infection source that will not be removed or debrided within 72 hours after randomization.
- •brain abscess or meningitis.
- •community acquired pneumonia or known polymicrobial bacteremia
研究组 & 干预措施
CF-301
Patients will receive a single IV infusion of CF-301 in addition to standard of care (SOC) antibacterial therapy selected by the investigator.
干预措施: CF-301 (Biological)
Placebo
Patients will receive a single IV infusion of placebo in addition to standard of care (SOC) antibacterial therapy selected by the investigator.
干预措施: Placebo (Drug)
结局指标
主要结局
Clinical Outcome at Day 14
时间窗: Day 14
Description of clinical outcome in the Microbiological Intent-to-Treat (mITT) population. Responder (clinical outcome of improvement or response) was defined as survival with improvement or resolution of attributable signs and symptoms, and without new signs or symptoms, new foci of infection, change in antibiotics due to non-response, complications of S. aureus, or further surgery or medical intervention to treat S. aureus.
CF-301 Maximum Plasma Concentration (Cmax)
时间窗: Pre-dose and at 0.5, 1.5, 2, 2.25, 3, 4, 8, 14, 24, and 48 hours after the start of CF-301 infusion
CF-301 plasma concentrations at specified timepoints.
Incidence of Adverse Events [Safety and Tolerability]
时间窗: Through Day 7, at Test of Cure (TOC) between 56-70 days, and at Day 180
Number and percentage of patients with treatment-emergent adverse events (TEAEs)
CF-301 Area Under the Curve (AUC 0-t)
时间窗: Pre-dose and at 0.5, 1.5, 2, 2.25, 3, 4, 8, 14, 24, and 48 hours after the start of CF-301 infusion
CF-301 plasma concentrations at specified time points
次要结局
- Clinical Outcome at Test of Cure (TOC)(TOC between 56-70 days)
- Microbiological Eradication at Test of Cure (TOC)(TOC between 56-70 days)
- Clinical Outcome at End of Standard of Care Antibacterial Therapy (EOT)(EOT between 28-42 days)
- Clearance of Bacteremia at Day 14 After CF-301/Placebo Administration(Day 14)
- Microbiological Eradication at End of Standard of Care Antibacterial Therapy (EOT)(EOT between 28-42 days)
- Clinical Outcome at Day 7(Day 7)
- Clearance of Bacteremia at Day 7 After CF-301/Placebo Administration(Day 7)