An observational study in Lung Transplant Infection and Lung Transplant Rejection, sponsored by Capital Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-07.
Sponsored by Capital Medical University · Observational
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).
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 100 is below the median of 240 across 2,136 observational studies indexed under Infections.
Browse Infections studies →Capital Medical University is the lead sponsor of 283 studies on the registry; 92 are open to participants now.
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100 patients with lung transplantation who meet the below inclusion criteria will be recruited in China-Japan Friendship Hospital in Beijing,China.
Exclusion Criteria:
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The progression rates from upper respiratory tract infection to lower respiratory tract infection within 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.
Time frame: 40 days after diagnosis
Mortality rate within 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
Time frame: 90 days after diagnosis of respiratory viral infections
Explore the lung microbiome dynamics within one year 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)
Time frame: 1 year follow-up after lung transplantation
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
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)
Time frame: 3 years follow-up after lung transplantation
Plan to share: Undecided
This study is status unknown, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Capital Medical University