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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03545919
Enrollment
100
Registered
2018-06-04
Start date
2018-08-05
Completion date
2022-06-01
Last updated
2018-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Transplant Infection, Lung Transplant Rejection

Keywords

respiratory viral infections, chronic lung allograft dysfunction, lung microbiome

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.

Interventions

None listed

Sponsors

China-Japan Friendship Hospital
CollaboratorOTHER
Chinese Academy of Medical Sciences
CollaboratorOTHER
Capital Medical University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

\-

Design outcomes

Primary

MeasureTime frameDescription
The progression rates from upper respiratory tract infection to lower respiratory tract infection within 40 days after diagnosis.40 days after diagnosisCARV 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 infections90 days after diagnosis of respiratory viral infectionsCARV 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 transplantationComplete 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)
Whether chronic lung allograft dysfunction occurs for individuals after 3 years follow-up after lung transplantation and find the relationship between lung microbiome and CLAD3 years follow-up after lung transplantationComplete 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)

Countries

China

Contacts

Primary ContactSi si Du, Ph.D
dusisi511@126.com86 13512916908
Backup ContactBin Cao, MD
caobin_ben@163.com86-010-84206264

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026