A Double-Blind, Placebo-controlled Parallel Group, Phase II Dose-Ranging Study of Nebulized Amikacin Delivered Via the Pulmonary Drug Delivery System (PDDS) in Ventilated Patients With Nosocomial Pneumonia Due to Gram Negative Organisms
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 69
- 主要终点
- Proportion of patients who achieve a C(max) for amikacin in tracheal aspirates at least 25 times greater than the reference MIC for hospital-acquired organisms and an AUC (0-24 hr) / MIC ratio that is 100 or greater on Day 1
研究概览
简要总结
This study is part of a research program too see if amikacin delivered as an aerosol directly to the lungs in combination with IV antibiotic therapy can help intubated patients with gram-negative pneumonia get better faster than when given intravenous antibiotics alone. The primary purpose of this study is to determine the correct dose of amikacin which is delivered directly to the lungs as an aerosol via an investigational device called the Pulmonary Delivery Device System (PDDS).
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
- Triple (Participant, Care Provider, Investigator)
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 and female patients 18 years of age or older with a clinical diagnosis of VAP, HAP or HCAP who are expected to be on mechanical ventilation for at least 3 days
排除标准
- •Patients with compromised of suppressed immune systems, severe hypoxemia, PEEP>15cm H2O, creatinine>2 mg/dL, or who are pregnant
研究组 & 干预措施
Arm 1
干预措施: Amikacin (BAY41-6551) (Drug)
Arm 2
干预措施: Amikacin (BAY41-6551) (Drug)
Arm 3
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of patients who achieve a C(max) for amikacin in tracheal aspirates at least 25 times greater than the reference MIC for hospital-acquired organisms and an AUC (0-24 hr) / MIC ratio that is 100 or greater on Day 1
时间窗: Day 1
次要结局
- Mean C(max) and mean AUC of amikacin in tracheal aspirates(Day 1 and Day 3 of treatment period)
- Mean ratio of C (max) / MIC and mean ratio of AUC (0-24 hr) / MIC(Day 1 and Day 3 of treatment period)
- Clinical cure rate(Test of cure visit (7 days post last treatment dose))
- Microbiological eradication rate of identified pathogens(Test of cure visit (7 days post last treatment dose))
- Microbiological persistence rate(Test of cure visit (7 days post last treatment dose))
- New infection rate(Test of cure visit (7 days post last treatment dose))
- Assessment of adverse events related to drug or device(Treatment period, early post treatment period, test of cure visit, and late post treatment)
- Assessment of abnormal laboratory values(Treatment period, early post treatment period, test of cure visit, and late post treatment)