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

Sponsor
Capital Medical University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03545919
Collaborator
China-Japan Friendship Hospital (Other), Chinese Academy of Medical Sciences (Other)
100
1
45.9
2.2

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Clinical Significance of Community-acquired Respiratory Virus Infection and Longitudinal Analysis of the Lung Microbiome in Lung Transplantation
    Anticipated Study Start Date :
    Aug 5, 2018
    Anticipated Primary Completion Date :
    Jun 1, 2022
    Anticipated Study Completion Date :
    Jun 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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

    3. 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)

    4. 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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 1.Patients with lung transplantation. 2.The patients who agree to participate in this study and sign informed consent.
    Exclusion Criteria:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 China-Japan Friendship Hospital Beijing China 100029

    Sponsors and Collaborators

    • Capital Medical University
    • China-Japan Friendship Hospital
    • Chinese Academy of Medical Sciences

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bin Cao, Doctor of Medicine, Capital Medical University
    ClinicalTrials.gov Identifier:
    NCT03545919
    Other Study ID Numbers:
    • 2018-20-K15
    First Posted:
    Jun 4, 2018
    Last Update Posted:
    Aug 7, 2018
    Last Verified:
    Aug 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Bin Cao, Doctor of Medicine, Capital Medical University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 7, 2018