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临床试验/NCT01025921
NCT01025921已完成不适用

Study of Inhaled Antibiotics for Prevention of Tracheobronchitis and Ventilator Associated Pneumonia

University of Thessaly1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2009年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
84
试验地点
1
主要终点
Incidence of tracheobronchitis and ventilator associated pneumonia

研究概览

简要总结

We aim to study whether the use of inhaled antibiotics may have an impact on the incidence of tracheobronchitis and pneumonia associated with the use of mechanical ventilation. The investigators hypothesize that this could be possible by decreasing the population of gram negative germs that colonize the lumen of tracheal tube and upper airways.

详细描述

INTRODUCTION Gram-negative bacteria have recently become endemic in many ICUs around the world. Ventilator associated pneumonia (VAP) is relatively common and its parenteral treatment often leads to low and sub-therapeutic concentrations of antibiotics in the lung. Ventilator associated tracheobronchitis (VAT) is characterized by fever, purulent sputum, positive cultures of tracheal aspirates secretions and the absence of new pulmonary infiltrates on CXR. This entity is of particular interest because it is an intermediate step in the pathogenesis of VAP (between colonization and VAP itself) and prolongs mechanical ventilatory support. Inhaled antibiotics achieve high (both peak and trough) concentrations in respiratory secretions. Endobronchial antibiotics have been given to non-cystic fibrosis patients for prevention of VAP. Colistimethate sodium (colistin) given by instillation decreased the incidence of Gram-negative pneumonia and did not lead to the development of colistin resistant bacteria.

AIM

The study is a prospective open label randomized study which aims to clarify the effect of colistin to:

  1. The incidence of VAP The incidence of VAT
  2. Mechanical ventilation free days
  3. Incidence of multidrug resistant bacteria in tracheal aspirates cultures

METHODS Settings: The study will be performed in the ICU of the University of Larissa (12 beds).

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
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

入选标准

  • All intubated and tracheostomized patients, older than 18 years old with duration of intubation of 48 hours.

排除标准

  • Purulent sputum within 48 hours from admission
  • Pneumonia within 48 hours of intubation
  • New chest X ray infiltrate
  • Advanced COPD that led to intubation
  • Pregnancy
  • Allergy to colistin
  • Resistance of the bacterial strain to colistin

研究组 & 干预措施

Inhaled colistin

Placebo Comparator

They will receive inhaled colistin three times daily for 10 days.

干预措施: colistin (Tadim) (Drug)

Inhaled normal saline

Placebo Comparator

Inhaled normal saline three times daily for 10 days

干预措施: inhaled normal saline (Other)

结局指标

主要结局

Incidence of tracheobronchitis and ventilator associated pneumonia

时间窗: 30 days

次要结局

  • Ventilator free days and ICU length of stay(30 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Efstratios Manoulakas

Professor and ICU Director Zakynthinos Epaminondas

University of Thessaly

研究点 (1)

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