A Multicenter, Randomized, Controlled Trial Comparing the Safety and Effectiveness of SURFAXIN® (Lucinactant) Delivered Via Bronchopulmonary Segmental Lavage to Standard of Care in Patients With Acute Respiratory Distress Syndrome (ARDS).
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Incidence of Patients Being Alive and Not Receiving Mechanical Ventilation for ≥48 Hours at the End of Day 28.
研究概览
简要总结
Lung wash with KL₄Surfactant of individual lung segments using a bronchoscope compared to usual care alone consisting primarily of assisted (mechanical) ventilation in patients with acute respiratory distress syndrome(ARDS).
详细描述
This is a multinational, multicenter, two-part, Phase 2 study that will evaluate the tolerability, safety, and efficacy of KL₄Surfactant in adult ARDS patients when administered by sequential bronchoscopic lavage into each of the 19 bronchopulmonary segments of the lung and as a bolus instillation into each lung.
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
- None
入排标准
- 年龄范围
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Intubated and required mechanical ventilation support
- •Met the criteria for ARDS
- •Partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) ≤ 200 mmHg and ≥ 60 mmHg within 60 minutes before randomization
- •Mean blood pressure was ≥ 60 mmHg immediately before randomization
排除标准
- •Had ARDS due solely to a major trauma
- •Was currently participating in another clinical trial or received an experimental drug or device within the previous month
- •A woman of childbearing age, unless pregnancy was excluded by a negative urine hCG test or if the subject was surgically incapable of childbearing
- •Had a previous episode of ARDS that resolved and then recurred during the current hospitalization
- •Had a disease that was sufficiently advanced, in the best judgment of the Principal Investigator, to markedly limit life expectancy to < 6 months
- •Was known to have AIDS or symptomatic HIV (CD4 counts <500). Subjects with asymptomatic HIV were not excluded
- •Received chemotherapy or radiation within the previous 90 days
- •Received an organ transplant other than corneal transplants
- •Received, or was currently receiving, immunosuppression therapy within the last 6 months
- •Had severe neurological damage or the presence of a disease that was likely to significantly prevent weaning from the ventilator
- •Had a best Glasgow Coma Score (GCS) of ≤ 8 or an intracranial pressure ≥ 20 cm H2O prior to the institution of sedatives or paralysis
研究组 & 干预措施
A.1 Lucinactant
3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours.
干预措施: A.1 Lucinactant (Drug)
A.2 Lucinactant
3 30-mL aliquots per bronchopulmonary segment using concentrations of 10, 10, and 10 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
干预措施: A.2 Lucinactant (Drug)
A.3 Lucinactant
2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
干预措施: A.3 Lucinactant (Drug)
A.4 Lucinactant
2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
干预措施: A.4 Lucinactant (Drug)
B.1 Lucinactant
2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
干预措施: B.1 Lucinactant (Drug)
B.2 Lucinactant
2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
干预措施: B.2 Lucinactant (Drug)
B.3 SoC
Received standard ARDS management and ICU care (Standard of Care [SOC]). Included, but was not limited to, support with oxygen, conventional mechanical ventilation, sedations, and paralysis.
干预措施: B.3 SoC (Other)
结局指标
主要结局
Incidence of Patients Being Alive and Not Receiving Mechanical Ventilation for ≥48 Hours at the End of Day 28.
时间窗: Through 28 days
次要结局
- Days in ICU(Through 28 days)
- Mortality(Through 28 days)