NCT02096328已完成2 期
A Phase II, Open-label, Multi-center Study to Assess Pharmacokinetics (PK), Safety and Efficacy of POL7080 Co-administered With Standard of Care (SoC) Treatment in Patients With Ventilator- Associated Pneumonia (VAP) Due to Suspected or Documented Pseudomonas Aeruginosa Infection.
Polyphor Ltd.10 个研究点 分布在 2 个国家目标入组 25 人开始时间: 2013年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 10
- 主要终点
- To measure the plasma concentrations of POL7080
研究概览
简要总结
To investigate the pharmacokinetic characteristics of POL7080 co-administered with SoC during 10 to 14 days of treatment in VAP patients due to suspected or documented Pseudomonas aeruginosa infection
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Male and female patients ≥18 years of age diagnosed with VAP , i.e., pneumonia that arises more than 96 hours after endotracheal intubation documented or suspected to be due to Pseudomonas aeruginosa
- •Respiratory specimen suitable for culture and Gram stain collected before starting the treatment
- •Written Informed consent from the patient's legally acceptable representative or a relative
排除标准
- •Patients with known hypersensitivity to fluoroquinolones, carbapenems, cephalosporin, penicillin (beta-lactam antibiotics) or aminoglycoside antibiotics (i.e. all available SoC antibiotics); patients with a clinically significant history of drug allergies and history of anaphylactic reaction and patients with active allergic conditions at the time of screening
- •Known or suspected pulmonary conditions which are likely to interfere with the therapeutic response or might have additional impact on pharmacokinetics
- •Patients with Acute Physiology and Chronic Health Evaluation II (APACHE II) score >25
- •Presence of septic shock at the time of evaluation for study entry
- •History of lung transplant
- •Patients with known HIV infection with CD4+ (cluster of differentiation 4) cell count < 200/mm3
- •Concomitant morbidity of such severity that the patient is likely to die or present with serious medical conditions within 7 days of study entry
- •Patients with impaired renal function
- •Patients who are currently enrolled in, or have not yet completed at least 30 days since ending another investigational device or drug trial or are receiving other investigational agent
研究组 & 干预措施
POL7080, Anti-pseudomonal antibiotics
Experimental
POL7080 daily co-administered with standard of care treatment
干预措施: POL7080 (Drug)
结局指标
主要结局
To measure the plasma concentrations of POL7080
时间窗: Day 3 and Day 6
PK profile of POL7080 will be determined on Day 3 and Day 6.
次要结局
- Adverse Events(Daily assessment up to 34 days from informed consent.)
- Laboratory abnormalities(Day 4, Day 6, Day 10, Day 15, Day 24 and Day 34)
研究者
研究点 (10)
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