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

Lung Transplant Rejection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03545919
• Other study ID #: 2018-20-K15
• Status: Recruiting
• Start date: August 5, 2018
• Est. completion date: June 1, 2022

Study information

• Verified date: August 2018
• Source: Capital Medical University
• Contact: Si si Du, Ph.D
• Phone: 86 13512916908
• Email: dusisi511[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Lung Transplant Infection
• Lung Transplant Rejection
• Virus Diseases

Locations

Country	Name	City	State
China	China-Japan Friendship Hospital	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Capital Medical University	China-Japan Friendship Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

References & Publications (8)

Bernasconi E, Pattaroni C, Koutsokera A, Pison C, Kessler R, Benden C, Soccal PM, Magnan A, Aubert JD, Marsland BJ, Nicod LP; SysCLAD Consortium. Airway Microbiota Determines Innate Cell Inflammatory or Tissue Remodeling Profiles in Lung Transplantation. — View Citation

Borewicz K, Pragman AA, Kim HB, Hertz M, Wendt C, Isaacson RE. Longitudinal analysis of the lung microbiome in lung transplantation. FEMS Microbiol Lett. 2013 Feb;339(1):57-65. doi: 10.1111/1574-6968.12053. Epub 2012 Dec 20. — View Citation

Bridevaux PO, Aubert JD, Soccal PM, Mazza-Stalder J, Berutto C, Rochat T, Turin L, Van Belle S, Nicod L, Meylan P, Wagner G, Kaiser L. Incidence and outcomes of respiratory viral infections in lung transplant recipients: a prospective study. Thorax. 2014 — View Citation

Chambers DC, Yusen RD, Cherikh WS, Goldfarb SB, Kucheryavaya AY, Khusch K, Levvey BJ, Lund LH, Meiser B, Rossano JW, Stehlik J; International Society for Heart and Lung Transplantation. The Registry of the International Society for Heart and Lung Transpla — View Citation

Mouraux S, Bernasconi E, Pattaroni C, Koutsokera A, Aubert JD, Claustre J, Pison C, Royer PJ, Magnan A, Kessler R, Benden C, Soccal PM, Marsland BJ, Nicod LP; SysCLAD Consortium. Airway microbiota signals anabolic and catabolic remodeling in the transplan — View Citation

Peghin M, Hirsch HH, Len Ó, Codina G, Berastegui C, Sáez B, Solé J, Cabral E, Solé A, Zurbano F, López-Medrano F, Román A, Gavaldá J. Epidemiology and Immediate Indirect Effects of Respiratory Viruses in Lung Transplant Recipients: A 5-Year Prospective St — View Citation

Seo S, Gooley TA, Kuypers JM, Stednick Z, Jerome KR, Englund JA, Boeckh M. Human Metapneumovirus Infections Following Hematopoietic Cell Transplantation: Factors Associated With Disease Progression. Clin Infect Dis. 2016 Jul 15;63(2):178-85. doi: 10.1093/ — View Citation

Willner DL, Hugenholtz P, Yerkovich ST, Tan ME, Daly JN, Lachner N, Hopkins PM, Chambers DC. Reestablishment of recipient-associated microbiota in the lung allograft is linked to reduced risk of bronchiolitis obliterans syndrome. Am J Respir Crit Care Med — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	40 days after diagnosis
Primary	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	90 days after diagnosis of respiratory viral infections
Primary	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)	1 year follow-up after lung transplantation
Primary	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)	3 years follow-up after lung transplantation