A Phase 2 Proof-of-concept Study to Evaluate the Efficacy and Safety of MEDI3902 in Mechanically Ventilated Patients for the Prevention of Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa
研究概览
简要总结
Clinical trial looking to evaluate the efficacy and safety of MEDI3902 in mechanically ventilated participants for the prevention of nosocomial pneumonia caused by Pseudomonas aeruginosa.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Colonized with P aeruginosa, expected to require prolonged intubation and mechanical ventilation, without any evidence of active pneumonia.
排除标准
- •P aeruginosa disease at randomisation; lung injury score consistent with pneumonia; current lung disease; currently receiving protocol-specified Anti-P aeruginosa antibiotics, moribund participants.
研究组 & 干预措施
MEDI3902 500 mg
Participants will receive a single intravenous (IV) dose of 500 mg MEDI3902.
干预措施: MEDI3902 (Drug)
Placebo
Participants will receive a single IV dose of placebo matched to MEDI3902.
干预措施: Placebo (Other)
MEDI3902 1500 mg
Participants will receive a single IV dose of 1500 mg MEDI3902.
干预措施: MEDI3902 (Drug)
结局指标
主要结局
Percentage of Participants With Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa
时间窗: Day 1 through Day 22
Percentage of participants with nosocomial pneumonia caused by Pseudomonas aeruginosa is reported.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
时间窗: Day 1 through Day 50
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
时间窗: Day 1 through Day 50
An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Number of Participants With Treatment-emergent Adverse Events of Special Interest (TEAESI)
时间窗: Day 1 through Day 50
An AESI is one of scientific and medical interest specific event for understanding of the study drug and may require close monitoring and rapid communication by the investigator to the sponsor. An AESI may be serious or non-serious.
次要结局
- Maximum Observed Concentration (Cmax) of MEDI3902(Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50)
- Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3902(Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50)
- Clearance (CL) of MEDI3902(Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50)
- Percentage of Participants Maintaining MEDI3902 Serum Levels Above the Target Level (1.7 µg/mL) Through 21 Days Post Dose(Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, and Day 22)
- Terminal Elimination Half-life (t1/2) of MEDI3902(Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50)
- Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI3902 Treatment(Day 1 (predose), Day 15, Day 29, Day 50)