Efficacy Study of Colistimethate Sodium Inhalation in Patients With Ventilator-associated Pneumonia
2021年3月11日 更新者：National Taiwan University Hospital
Prospective Observation of Colistimethate Sodium Inhalation in Patients With Ventilator-associated Tracheobronchitis/Pneumonia or Lower Respiratory Tract Colonization by Multidrug Resistant Gram-negative Bacteria
There might be additional benefit on clinical outcomes from adjunctive colistimethate sodium inhalation as therapy for multidrug resistant Gram-negative ventilator-associated pneumonia.
研究概览
地位
终止
条件
详细说明
Besides, early antibiotics intervention might be benefit for patients with ventilator-associated tracheobronchitis or lower airway colonization with multidrug resistant Gram-negative bacteria.
研究类型
观察性的
注册 (实际的)
49
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
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Taipei、台湾
- National Taiwan University Hospital
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
20年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
Patients in medical intensive care unit with ventilator use
描述
Inclusion Criteria:
- age ≥ 20 years old
- medical ICU patients with invasive ventilator use ≥ 48 hours
- multidrug resistant Gram-negative bacteria obtained from lower respiratory tract
Exclusion Criteria:
- pregnancy
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
|
Colistimethate sodium inhalation
Colistimethate sodium inhalation for patients with ventilator-associated tracheobronchitis, pneumonia or lower respiratory tract colonization by multidrug resistant Gram-negative bacteria. Additional intravenous colistimethate sodium for patients with ventilator-associated pneumonia |
|
saline inhalation
saline inhalation for patients with ventilator-associated tracheobronchitis, pneumonia or lower respiratory tract colonization by multidrug resistant Gram-negative bacteria.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
clinical cure rate
大体时间：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)
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From date of starting colistimethate sodium to 28th days or til discharge from hospital, whichever came first, assessed up to 28 days
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
intensive care unit stay
大体时间：From date of starting colistimethate sodium to discharge date of intensive care unit, assessed up to 3 months
|
From date of starting colistimethate sodium to discharge date of intensive care unit, assessed up to 3 months
|
|
hospital stay
大体时间：From date of starting colistimethate sodium to discharge date of hospital, assessed up to 3 months
|
From date of starting colistimethate sodium to discharge date of hospital, assessed up to 3 months
|
|
all cause mortality
大体时间：From date of starting colistimethate sodium to 28th days or til death, whichever came first, assessed up to 28 days
|
From date of starting colistimethate sodium to 28th days or til death, whichever came first, assessed up to 28 days
|
|
ventilator-associated pneumonia-related mortality
大体时间：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
|
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
|
|
microbiologic eradication in colonization patients
大体时间：From date of starting colistimethate sodium to 28th days or til discharge from hospital, whichever came first, assessed up to 28 days
|
From date of starting colistimethate sodium to 28th days or til discharge from hospital, whichever came first, assessed up to 28 days
|
|
ventilator-associated pneumonia rate
大体时间：From date of starting colistimethate sodium to discharge date of hospital, assessed up to 3 months
|
From date of starting colistimethate sodium to discharge date of hospital, assessed up to 3 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Wang-Huei Sheng, M.D. Ph.D、Center of Infection Control of National University Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年10月1日
初级完成 (实际的)
2016年2月4日
研究完成 (实际的)
2017年8月31日
研究注册日期
首次提交
2013年10月22日
首先提交符合 QC 标准的
2013年10月28日
首次发布 (估计)
2013年11月3日
研究记录更新
最后更新发布 (实际的)
2021年3月16日
上次提交的符合 QC 标准的更新
2021年3月11日
最后验证
2013年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.