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临床试验/NCT06114784
NCT06114784招募中不适用

Identification of Lung and Intestinal Microbiome and Host Susceptibility in Severe Pneumonia, a Prospective, Multicenter Cohort Study

First Affiliated Hospital of Zhejiang University15 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2023年9月25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
2,000
试验地点
15
主要终点
The correlation between lung microbiome and disease prognosis

研究概览

简要总结

This study was a prospective multicenter cohort of severe pneumonia. And by collecting clinical samples to clarify the correlation between lung microbiome, intestinal microbiome, host susceptibility, and prognosis of severe pneumonia patients.

详细描述

The human lung and intestinal microbiota play an important role in human health. At present, the correlation between lung and intestinal microbiota in severe pneumonia patients and host susceptibility is limited to small sample, single center studies. Due to sample size limitations, the pathogenesis of severe pneumonia caused by many pathogens remains unclear. This study plans to construct sputum, alveolar lavage fluid, feces, and whole blood samples of severe pneumonia patients admitted to the ICU from 2023 to 2025, and collect clinical data from patients to identify changes in lung and intestinal microbiome, host susceptibility, and disease progression risk in different groups of patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • New lung infection that meets one of the following definitions: the patient receives mechanical ventilation (invasive or non-invasive) due to acute respiratory failure, with a PEEP level of 5cm or above; Patients receiving high flow oxygen therapy with a FiO2 of 50% or more and a PaO2: FiO2 ratio below 300

排除标准

  • Expected length of stay in ICU is less than 1 day

结局指标

主要结局

The correlation between lung microbiome and disease prognosis

时间窗: 60 days

1. Identification of microbial gene profiles; 2. Analysis of host health dynamics and trends; 3. Identification of host gene mutations; 4. Preliminary model construction; 5. Model optimization and evaluation.

次要结局

未报告次要终点

研究者

发起方
First Affiliated Hospital of Zhejiang University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lingtong Huang, MD

Doctor

First Affiliated Hospital of Zhejiang University

研究点 (15)

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