跳至主要内容
临床试验/NCT04208945
NCT04208945Unknown不适用

The Effect of Nebulized Colistin on the Incidence of Gram Negative Bacterial Ventilator Associated Pneumonia in Intensive Care Unit Patients.

University of Thessaly3 个研究点 分布在 1 个国家目标入组 152 人开始时间: 2019年12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
入组人数
152
试验地点
3
主要终点
The 28th day incidence of gram negative bacterial Ventilator-associated-pneumonia (VAP)

研究概览

简要总结

Colistin is used as an elective treatment of infections of multi drug resistant gram negative bacteria. Until now colistin is used in the therapeutic regimen of these infections intravenous or nebulized. There are a plenty of studies about the efficacy of nebulized colistin in the therapy of pseudomonas aeruginosa pneumonia in patients with cystic fibrosis and in the therapy of ventilator associated pneumonia in ICU. On the other hand there are only a few studies about the use of nebulized colistin in the prevention of ventilator associated pneumonia whereas the role of nebulized colistin in the prevention of severe forms of pneumonia such as VAP due to multi drug resistant gram negative bacteria are limited.

This double blinded randomized trial aim to investigate the effect of nebulized colistin on the incidence of patients with due to gram negative bacteria in the ICU compared to nebulized normal saline.

详细描述

INTRODUCTION Pneumonia in the intensive care unit (ICU) constitutes the most frequent infection and is most often associated with the application of the mechanical ventilation. VAP (Ventilator - Associated Pneumonia) is defined as the nosocomial pneumonia in a patient on mechanical ventilatory support (by endotracheal tube or tracheostomy) for more than 48 hours. The risk for such complication is proportionally increased with the duration of hospitalization. The symptoms include the appearance of pulmonary infiltrate, fever, leukocytosis and purulent tracheobronchial secretions although this symptomatology is not always present. VAP is usually caused by nosocomial species and especially by gram negative bacteria such as Acinetobacter baumannii, Pseudomonas aeruginosa, Klebsiella pneumoniae.

VAP is frequently complicated with the entry of bacteria in the circulation of blood resulting in bacteremia and sepsis. In this respect, this disorder is associated with substantial morbidity and devastating costs of hospitalization. Notably, the cost of one episode of VAP is estimated in 57000 $ per occurrence.

Inhaled antibiotics achieve high (both peak and trough) concentrations in respiratory secretions. Endobronchial antibiotics have been given initially in cystic fibrosis patients for the prevention of Pseudomonas aeruginosa pneumonia. More recently, some studies reported on the use of endobronchial antibiotics in non-cystic fibrosis patients for VAP treatment. There are only a few, relatively small, one-centre studies about the prevention of VAP; in those studies Colistin was given by instillation or nebulization and decreased the incidence of Gram-negative pneumonia.

AIM To study prospectively the effect of nebulized colistin on the incidence of Ventilator Associated Pneumonia due to gram negative bacteria in the ICU.

STUDY DESIGN Parallel two group blinded randomized controlled clinical trial. The trial medication will be commenced within 12 hours of randomization. The treatment group will receive nebulized colistin (500000 international units of colistimethate sodium, three times a day) for 10 days.

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

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Inhaled colistin

Experimental

Inhaled colistin three times daily for 10 days

干预措施: Colistin (Drug)

结局指标

主要结局

The 28th day incidence of gram negative bacterial Ventilator-associated-pneumonia (VAP)

时间窗: 28 days

The 28th day incidence will be estimated as the percentage (%) of patients with at least an episode of gram negative bacterial Ventilator-associated- pneumonia (VAP), from randomization to the 28th day, among patients hospitalised in the intensive care unit. Diagnosis of VAP will be based on clinical criteria and will require microbiological confirmation

次要结局

  • Colistin resistant bacteria in tracheobronchial aspirate (TBA) or blood(28 days)
  • 28 day mortality(28 days)

研究者

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

Stratos Manoulakas

MD, PhD in ICU, (Professor and ICU director Zakynthinos Epaminondas)

University of Thessaly

研究点 (3)

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