Clinical Significance of Community-acquired Respiratory Virus Infection and Longitudinal Analysis of the Lung Microbiome in Lung Transplantation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Whether chronic lung allograft dysfunction occurs for individuals after 3 years follow-up after lung transplantation and find the relationship between lung microbiome and CLAD
研究概览
简要总结
The purpose of this study is to evaluate the clinical significance of community-acquired respiratory virus (CARV) infection in patients with lung transplantation;Explore the lung microbiome dynamics within one year after lung transplantation;Find the relationship between lung microbiome and chronic lung allograft dysfunction(CLAD).
详细描述
Title:Clinical Significance of Community-acquired Respiratory Virus Infection and Longitudinal Analysis of the Lung Microbiome in Lung Transplantation.
Background:Infection affects the short-term prognosis of patients with lung transplantation and chronic lung allograft dysfunction(CLAD) limits their long-term survival.It is important to provide more theoretical support for early diagnosis and treatment of acute respiratory tract infection and CLAD in patients with lung transplantation.
Study Objectives:Evaluate the clinical significance of community-acquired respiratory virus (CARV) infection in patients with lung transplantation;Explore the lung microbiome dynamics within one year after lung transplantation;Find the relationship between lung microbiome and CLAD.
Study Design:A prospective and longitudinal study,following up the patients for 3 years.
Sample Size:100 cases. Study methods:CARV detection for respiratory specimens are performed during acute infection and routine re-testing in patients after lung transplantation,following up the patients who have positive findings to analyze the progression rates to lower respiratory tract infection,mortality rate within 90 days and risk factors associated with progression and death.For HRV/CoVs/HBoV detecting positive patients, consecutively collect respiratory specimens to quantitate viral load and combine virus serology to further confirm their pathogenicity on host.Complete a longitudinal 16S ribosomal RNA and metagenomics survey of the lung microbiome on respiratory samples collected from routine testing or re-testing（pre-operation,24 hours after the operation，day 3, day 7, week 2, week 3, month 1, month 3, month 6, month 9, month 12 , month 18, month 24, month 30, month 36) to explore the lung microbiome dynamics within one year after lung transplantation and find the relationship between lung microbiome and CLAD after 3 years follow-up.Besides,collect the peripheral blood of some patients for transcriptome and/or whole genome sequencing to screen for the host susceptibility genes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 否
入选标准
- •1.Patients with lung transplantation. 2.The patients who agree to participate in this study and sign informed consent.
排除标准
- 未提供
结局指标
主要结局
Whether chronic lung allograft dysfunction occurs for individuals after 3 years follow-up after lung transplantation and find the relationship between lung microbiome and CLAD
时间窗: 3 years follow-up after lung transplantation
Complete a longitudinal 16S ribosomal RNA and metagenomics survey of the lung microbiome on respiratory samples collected from routine testing or re-testing（24 hours after the operation，month 3, month 6, month 9, month 12 , month 18, month 24, month 30, month 36)
The progression rates from upper respiratory tract infection to lower respiratory tract infection within 40 days after diagnosis.
时间窗: 40 days after diagnosis
CARV detection for respiratory specimens are performed during acute infection and routine re-testing in patients after lung transplantation,following up the patients who have positive findings to analyze the progression rates to lower respiratory tract infection.
Mortality rate within 90 days after diagnosis of respiratory viral infections
时间窗: 90 days after diagnosis of respiratory viral infections
CARV detection for respiratory specimens are performed during acute infection and routine re-testing in patients after lung transplantation,following up the patients who have positive findings to analyze mortality rate within 90 days after diagnosis of respiratory viral infections
Explore the lung microbiome dynamics within one year after lung transplantation.
时间窗: 1 year follow-up after lung transplantation
Complete a longitudinal 16S ribosomal RNA and metagenomics survey of the lung microbiome on respiratory samples collected from routine testing or re-testing（pre-operation,24 hours after the operation，day 3, day 7, week 2, week 3, month 1, month 3, month 6, month 9, month 12)
次要结局
未报告次要终点
研究者
Bin Cao
Doctor of Medicine
Capital Medical University