A Phase 3, Randomized, Double-blind, Placebo-controlled, Single-dose Study to Evaluate the Efficacy and Safety of Suvratoxumab in Mechanically Ventilated Adults and Adolescents for the Prevention of Nosocomial Pneumonia
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 27
- 主要终点
- Incidence of nosocomial all-cause pneumonia through 30 days post dose
研究概览
简要总结
Clinical trial looking at safety and efficacy of suvratoxumab in prevention of pneumonia caused by Staphylococcus aureus in high-risk patients
详细描述
This is a Phase 3, randomized, double-blind, placebo-controlled study evaluating the efficacy of a single IV dose of suvratoxumab in mechanically ventilated subjects in the ICU who are at high risk for S. aureus infections and who are currently free of active S. aureus-related disease but are colonized with S. aureus in the LRT.
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)
盲法说明
This study is a double-blind, randomized, controlled trial.
入排标准
- 年龄范围
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Colonized with Staphylococcus aureus;
- •Expected to require prolonged intubation and mechanical ventilation, without any evidence of active pneumonia.
排除标准
- •Staphylococcal disease at randomisation;
- •Lung injury score consistent with pneumonia;
- •Chronic tracheostomy patients;
- •The study subject is moribund
- •Receipt of anti- S. aureus systemic antibiotics
- •Active pulmonary disease
研究组 & 干预措施
AR-320 (Suvratoxumab)
Participants will receive a single intravenous (IV) dose of suvratoxumab on Day 0 of the study.
干预措施: Suvratoxumab (Biological)
Placebo
Participants will receive a single IV dose of placebo to survatoxumab on Day 0 of the study.
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of nosocomial all-cause pneumonia through 30 days post dose
时间窗: 30 days
All-cause pneumonia is based on clinical, radiographic, and microbiologic criteria. The percent reduction of the incidence of (% of patients with) nosocomial all-cause pneumonia, regardless of identified etiology, following administration of study drug through 30 days post dose
次要结局
- Number of participants with TESAE at 90 days(90 days)
- Number of participants with TEAESI at 90 days(90 days)
- Number of Participants with Nosocomial all-cause pneumonia or death through 30 days post dose(30 days)
- Number of Participants with Nosocomial S. aureus pneumonia through 30 days post dose(30 days)
- Number of Participants with Nosocomial S. aureus pneumonia through 90 days post dose(90 days)
- Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to Suvratoxumab(90 days)
- Number of participants with TEAE at 30 days(30 days)
- Suvratoxumab Maximum Observed Serum Concentration (Cmax)(90 days)
- Suvratoxumab Area under the Plasma Concentration-Time Curve (AUC)(90 days)