NCT01975350终止不适用
Prospective Observation of Colistimethate Sodium Inhalation in Patients With Ventilator-associated Tracheobronchitis/Pneumonia or Lower Respiratory Tract Colonization by Multidrug Resistant Gram-negative Bacteria
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- clinical cure rate
研究概览
简要总结
There might be additional benefit on clinical outcomes from adjunctive colistimethate sodium inhalation as therapy for multidrug resistant Gram-negative ventilator-associated pneumonia.
详细描述
Besides, early antibiotics intervention might be benefit for patients with ventilator-associated tracheobronchitis or lower airway colonization with multidrug resistant Gram-negative bacteria.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥ 20 years old
- •medical ICU patients with invasive ventilator use ≥ 48 hours
- •multidrug resistant Gram-negative bacteria obtained from lower respiratory tract
排除标准
- •concurrent use of other antimicrobial agents active for isolated multidrug resistant Gram-negative bacteria (as defined as resistant to carbapenem, fluoroquinolone, and anti-pseudomonas beta-lactams), such as tigecycline, aminoglycosides, and sulbactam
- •patients who refuse to receive any inhaled therapy
结局指标
主要结局
clinical cure rate
时间窗: From date of starting colistimethate sodium to 28th days or til discharge from hospital, whichever came first, assessed up to 28 days
including clinical improvement and microbiological outcome(eradication of the pathogen as no growth of the pathogen in the final culture of specimens during the entire hospitalization)
次要结局
- all cause mortality(From date of starting colistimethate sodium to 28th days or til death, whichever came first, assessed up to 28 days)
- ventilator-associated pneumonia rate(From date of starting colistimethate sodium to discharge date of hospital, assessed up to 3 months)
- intensive care unit stay(From date of starting colistimethate sodium to discharge date of intensive care unit, assessed up to 3 months)
- microbiologic eradication in colonization patients(From date of starting colistimethate sodium to 28th days or til discharge from hospital, whichever came first, assessed up to 28 days)
- hospital stay(From date of starting colistimethate sodium to discharge date of hospital, assessed up to 3 months)
- ventilator-associated pneumonia-related mortality(Death that occurred during the colistimethate sodium treatment period when the signs of pneumonia remained and as death due to septic shock, assessed up to 28 days)
研究者
研究点 (1)
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