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临床试验/NCT05300776
NCT05300776招募中不适用

A Multi-center Prospective Clinical Study of M-ROSE Combined With mNGS to Guide the Individualized Anti-infection Treatment, Prevention and Control of Drug-resistant Bacteria in Severe Hospital-acquired Pneumonia

Chinese PLA General Hospital1 个研究点 分布在 1 个国家目标入组 166 人开始时间: 2022年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
166
试验地点
1
主要终点
mortality

研究概览

简要总结

The purpose of this study is to determine the value of M-ROSE(microbiological rapid on-site evaluation)in severe hospital-acquired pneumonia.

详细描述

Severe hospital acquired pneumonia (SHAP) is the critical risk factor leading to the death of nosocomial infection patients. Rapid identification of pathogens, guidance of individualized treatment and rational application of antibiotics can not only improve the administration of antibiotics, but also reduce the production of multi drug resistant bacteria. Metagenomic second-generation sequencing (mNGS) is an important tool to quickly identify the pathogen in ICU. However, due to the low qualified rate of lower respiratory tract specimens in patients with SHAP, easily polluted, and the difficulty to determine whether microorganisms are infectious, colonizated or polluted, the value of mNGS was limited in the etiological diagnosis of SHAP. The bedside M-ROSE system established by our research team can determine whether the lower respiratory tract specimen is qualified, whether infection exists and the pathogen of infection within half an hour. Based on the previous work, this project plans to conduct a prospective multicenter, single blind, randomized controlled study under the guidance of M-ROSE and mNGS in the individualized anti-infection strategy of SHAP, to reduce the mortality of patients with SHAP; Combined with the third-generation sequencing, the standard analysis framework for the traceability and prevention and control of drug-resistant bacteria was established to clarify the transmission route of drug-resistant bacteria, so as to provide a new solution for the prevention and control of clinical multidrug-resistant bacteria.

研究设计

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

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

  • Clinical diagnosis of severe hospital-acquired pneumonia
  • Must have undergone bronchoalveolar lavage

排除标准

  • BALF samples were not sent for mNGS examination
  • Age < 18 years old
  • The hospitalization days ≤ 3
  • The clinical data are incomplete
  • Mechanical ventilation time > 60 days

结局指标

主要结局

mortality

时间窗: During the intervention.

Alive or Dead.

次要结局

  • Blood procalcitonin tread(During the intervention.)
  • Blood C-reactive protein(During the intervention.)
  • 28 day outcome(28 days after admission)
  • Blood interleukin 6 tread(During the intervention.)
  • Blood neutriphil ratio tread(During the intervention.)
  • Blood leukocyte ratio tread(During the intervention.)

研究者

发起方
Chinese PLA General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

wang kaifei

Clinical Professor

Chinese PLA General Hospital

研究点 (1)

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