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临床试验/NCT03921645
NCT03921645Unknown不适用

Use of Aaerosol Combined With Intravenous Antibiotics for the Treatment of Multidrug Resistant GNB Pneumonia

Shanghai 10th People's Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
1
主要终点
CPIS score changes

研究概览

简要总结

To investigate use of aerosol combined with intravenous antibiotics for the treat of multi-drug resistance gram negative bacterias diagnosed ventilator-associated pneumonia in intensive care unit in a hospital.

详细描述

Ventilator-associated pneumonia (VAP) refers to the endotracheal tube or tracheostomy patients pneumonia after 48h of mechanical ventilation, mechanical ventilation is one of the most common and most serious complications, hospital acquired is An important cause of pneumonia. According to the onset time of VAP, VAP can be divided into early-onset VAP and late-onset VAP. The time limit is mechanical ventilation for 4 days, in which early-onset VAP (mechanical ventilation ≤ 4d) is mainly caused by pathogens sensitive to most antibacterial drugs (such as methicillin-sensitive Staphylococcus aureus, Streptococcus pneumoniae, etc.); late-onset VAP ≥ 5D occur during mechanical ventilation, mainly caused by multi-drug resistant (multi-drug resistance, MDR) (such as P. aeruginosa, Acinetobacter baumannii, methicillin-resistant Staphylococcus aureus). Some early-onset VAPs can also be caused by MDR. Therefore, MDR has become the main pathogen of VAP, especially Gram-negative bacilli. Studies have shown that VDR caused by MDR has a mortality rate of 76% and an attributable mortality rate of 20-30%. Such bacteria are not sensitive to commonly used antibacterial drugs in the clinic, and sensitive antibiotics, such as aminoglycosides, have a large systemic side effect, thereby limiting clinical use. Therefore, in theory, nebulized inhaled sensitive antibiotics can achieve high drug concentrations in lung tissue, and lower blood concentrations can avoid or reduce systemic side effects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ・ After 48 hours of mechanical ventilation diagnosed VAP.

排除标准

  • who not meet the age limits,
  • used amikacin within 15 days,
  • allergic to amikacin,
  • APACHE II score > 35,
  • severe neutropenia unrelated to sepsis or meningitis,
  • unable to retain specimens

研究组 & 干预措施

aerosol combined group

Experimental

aerosol combined intravenous antibiotics group,amikacin 15mg/kg, qd

干预措施: aerosol antibiotics (Drug)

结局指标

主要结局

CPIS score changes

时间窗: 14 days

use clinical pulmonary infection score scale to evaluate score change from baseline for every patient

renal function changes

时间窗: 14 days

record changes in renal function assessed by SCr, blood urea nitrogen,etc.

次要结局

  • Drug resistance induction rate(14 days)
  • ventilator free days in 14 days(14 days)
  • 14-day mortality rate(14 days)

研究者

发起方
Shanghai 10th People's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sheng Wang MD PhD

Director, Principal investigator

Shanghai 10th People's Hospital

研究点 (1)

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