A Multicenter, Single-Dose, Uncontrolled, Open-label, One Group Study to Investigate the Pharmacokinetics of RO7223280 in Critically Ill Patients With Bacterial Infections
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 16
- 主要终点
- Plasma Concentrations of RO7223280
研究概览
简要总结
The main aim of the study is to investigate the plasma pharmacokinetics (PK) and safety of intravenous (IV) administration of a single dose of 400 milligrams (mg) or 600 mg RO7223280 in critically ill participants with bacterial infections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Illness requiring treatment in an intensive care unit (ICU) at the time of enrolment
- •Ongoing clinical syndrome meeting at least one of the following criteria:
- •HABP: bacterial pneumonia diagnosed after more than 48 hours of hospitalization or within 7 days after a hospital discharge
- •Ventilator-associated bacterial pneumonia (VABP): bacterial pneumonia diagnosed after more than 48 hours of mechanical ventilation or within 72 hours after weaning
- •Bacteremia confirmed by the presence of a bacterial pathogen in a blood culture drawn within 7 days prior to dosing and with the defined focus of infection.
- •For Cohort 4 only: mechanically ventilated participants who have a BAL procedure planned as part of routine practice for a day that can function as Day 1.
排除标准
- •Ongoing documented catheter-related bacteraemia as the sole ongoing infection
- •Major surgery within 48 hours prior to dosing or major surgery expected within 48 hours after the start of the infusion
- •Known chronic severe hepatic impairment (Child-Pugh class C). Note: acute severe hepatic impairment is not exclusionary
研究组 & 干预措施
Cohort 1
Bacteremia participants without pneumonia and who are not mechanically ventilated at screening will be enrolled in this cohort. Participants will receive RO7223280 on Day 1.
干预措施: RO7223280 (Drug)
Cohort 2
Participants with hospital-acquired bacterial pneumonia (HABP) and who are not mechanically ventilated at screening will be enrolled in this cohort. Participants will receive RO7223280 on Day 1.
干预措施: RO7223280 (Drug)
Cohort 3
Participants with mechanical ventilation at screening will be enrolled in this cohort. Participants will receive RO7223280 on Day 1.
干预措施: RO7223280 (Drug)
Cohort 4
Participants with mechanical ventilation who have a bronchoalveolar lavage (BAL) planned as a part of routine practice will be enrolled in this cohort. Participants will receive RO7223280 on Day 1.
干预措施: RO7223280 (Drug)
结局指标
主要结局
Plasma Concentrations of RO7223280
时间窗: Cohort 1-3: From Day 1 up to Day 3; Cohort 4: From Day 1 up to Day 5
次要结局
- Percentage of Participants With Adverse Events (AEs)(Cohort 1-3: From Day 1 up to Day 4; Cohort 4: From Day 1 up to Day 5)
- Percentage of Participants With Serious Adverse Events (SAEs)(Cohort 1-3: From Day 1 up to Day 4; Cohort 4: From Day 1 up to Day 5)
- Percentage of Participants Who Died Due to Any Cause(Cohort 1-3: From Day 1 up to Day 4; Cohort 4: From Day 1 up to Day 5)