Clinical Significance of Community-acquired Respiratory Virus Infection and Longitudinal Analysis of the Lung Microbiome in Lung Transplantation

• Conditions: Lung Transplant Rejection; Lung Transplant Infection

• Registration Number: NCT03545919
• Lead Sponsor: Capital Medical University

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study First Submitted: 2018-05-13
• Study First Submitted QC: 2018-05-22
• Study First Posted: 2018-06-04
• Status Verified: 2018-08
• Study Start: 2018-08-05
• Last Update Submitted: 2018-08-05
• Last Update Posted: 2018-08-07
• Primary Completion: 2022-06-01
• Study Completion: 2022-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 1.Patients with lung transplantation. 2.The patients who agree to participate in this study and sign informed consent.

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	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.	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	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.	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)

Trial Locations

Locations (1)

China-Japan Friendship Hospital; 🇨🇳 Beijing, China