A Randomized, Double-Blind, Placebo-Controlled Pilot Trial of KB001 in Mechanically-Ventilated Patients Colonized With Pseudomonas Aeruginosa
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- The safety and tolerability of a single dose of KB001.
研究概览
简要总结
Pseudomonas aeruginosa is an opportunistic pathogen that rarely causes disease in healthy people, but is a significant problem for critically ill or immunocompromised individuals. Experts estimate that there are greater than 100,000 patients in the United States, Europe and Japan where Pseudomonas pneumonia occurs. Patients with Pseudomonas pneumonia currently represent only about 20% of the patients in the hospital who get Pseudomonas infections.
详细描述
This trial will evaluate KB001 in patients in the intensive care setting who are receiving ventilator therapy and who have Pseudomonas infections. They will receive either placebo, or one of two dose levels of KB001, a Humaneered™, high-affinity antibody fragment that KaloBios is developing for the treatment of Pseudomonas aeruginosa (Pa) infections. This trial will evaluate the ability of KB001 to protect host epithelium and immune cells, and evaluate reduction of pulmonary Pa burden.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Provision of written informed consent obtained from patient or patient's surrogate if unconscious or altered sensorium
- •Age >18 years
- •On mechanical ventilation and expected to remain mechanically ventilated for at least 3 days
- •Documented pulmonary Pa colonization
排除标准
- •Patients with known chronic pulmonary infection with Pa (i.e., patients with cystic fibrosis)
- •Patient currently diagnosed with Pa VAP
- •Change in systemic antibiotic therapy active against Gram negative bacteria within 72 hours
- •Use of an investigational medication within 4 weeks prior to randomization
结局指标
主要结局
The safety and tolerability of a single dose of KB001.
时间窗: Day 28
次要结局
- To measure the pharmacodynamic effects of a single-dose of KB001.(Day 28)