跳至主要内容
临床试验/NCT07005466
NCT07005466已完成不适用

Clinical Study of Bronchoalveolar Lavage Combined With High-throughput Sequencing Technology in the Precise Diagnosis of Immunosuppressive Host Pneumonia

Nanfang Hospital, Southern Medical University1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2019年1月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
500
试验地点
1
主要终点
Sensitivity, specificity in pneumonia patients

研究概览

简要总结

High-throughput sequencing technology/Metagenomic next generation sequencing (mNGS) has extensive applications in fields such as whole-genome sequencing, transcriptome, gene expression regulation, and epigenetics. Because mNGS has the characteristics of large sequencing throughput, short time and high sensitivity, it can detect thousands of pathogens including bacteria, viruses, true bacteria and parasites, and is widely used in infectious diseases. In 2020, the "Expert Consensus on the Clinical Application of Metagenomic Second-Generation Sequencing Technology in Detecting Infectious Pathogens in China" proposed that for immunodeficient patients, mNGS can significantly increase the detection rate of pathogens and can be used as a first-line detection method. However, at present, there is no unified standard for the interpretation of mNGS results in the environment with bacteria in the respiratory tract, and there are not many studies on the efficacy of mNGS applied in the detection of bacteria and fungi. This study explored the clinical application value of mNGS in the pathogen detection of pneumonia in immunosuppressed hosts.

详细描述

Infection is the most common complication in immunosuppressed hosts, and lung infection is one of the leading causes of hospitalization and death in immunosuppressed hosts, and accurate pathogenetic diagnosis of pneumonia in immunosuppressed hosts remains challenging at present. Bronchoalveolar lavage is the standard method for sampling microorganisms in the lower respiratory tract, and with the progressive application of high-throughput sequencing (NGS) technology for pathogenetic testing and its success, we have clinically observed that bronchoalveolar lavage combined with NGS improves the rate of pathogenic diagnosis of pneumonia in the immunosuppressed host and benefits the patient. In this project, we plan to prospectively enroll patients with immunosuppressed host pneumonia and perform both bronchoalveolar lavage NGS and clinical conventional sputum culture, blood culture, TB-DNA test, fungal GM test, viral PCR test and other pathogenicity tests, and based on the above results, we will explore whether bronchoalveolar lavage in combination with NGS can increase the rate of pathogenic diagnosis of immunosuppressed host pneumonia and evaluate the effectiveness of the clinical value of NGS in serving as a tool for pneumonia detection and control and in optimizing antibiotic treatment strategies for pneumonia in immunosuppressed hosts.

This study compared the positive rate and accuracy rate of pathogen detection in immunosuppressive host pneumonia by mNGS and CMT, and explored the clinical value of bronchoalveolar lavage combined with high-throughput sequencing technology in the precise diagnosis of immunosuppressive host pneumonia. To increase the etiological diagnosis rate of pneumonia in immunosuppressed hosts, shorten the diagnosis time and improve its prognosis.

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 75 Years(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

结局指标

主要结局

Sensitivity, specificity in pneumonia patients

时间窗: 2021.01-2024.12

Sensitivity: the ratio of the number of positive cases detected within the experimental group diagnosed with the disease by the gold standard. Specificity: the ratio of the number of negative cases detected in the control group diagnosed as disease-free by the gold standard.

Positive predictive value (PPV), negative predictive value (NPV) in pneumonia patients

时间窗: 2021.01-2024.12

Positive predictive value: the proportion of positive diagnostic test results to be evaluated that are actually diseased, i.e., the percentage of positive results that are predictive of actual disease. Negative predictive value: the proportion of cases that are positive for a given disease among the diagnostic tests to be evaluated, i.e., the percentage of cases that can be predicted to be truly diseased from the positive results.

次要结局

  • Therapeutic success rate(2021.01-2024.12)
  • the proportion of cases in which an adverse event occurs.(2021.01-2024.12)
  • the average length of stay of patients in the hospital.(2021.01-2024.12)
  • Survival rate(2021.01-2024.12)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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