Lung Transplant InfectionNCT03545919
Clinical Significance of Community-acquired Respiratory Virus Infection and Longitudinal Analysis of the Lung Microbiome in Lung Transplantation
An observational study of Lung Transplant Infection and Lung Transplant Rejection, run by Capital Medical University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplant Infection, Lung Transplant Rejection
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 5 Aug 2018to 1 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 100 patients with lung transplantation who meet the below inclusion criteria will be recruited in China-Japan Friendship Hospital in Beijing,China.
Who may be able to join
- 1.Patients with lung transplantation. 2.The patients who agree to participate in this study and sign informed consent.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, 100029
Bin Cao, MD, 86-010-84206264, caobin_ben@163.com
Si si Du, Ph.D, 86 13512916908, dusisi511@126.com
About this study
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).
Read the 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.
- Keywords
- respiratory viral infections, chronic lung allograft dysfunction, lung microbiome
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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)
Measured: 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)
Measured: 3 years follow-up after lung transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start5 Aug 2018 (estimated)
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Lung Transplant InfectionStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- China-Japan Friendship Hospital, Chinese Academy of Medical Sciences
- Responsible party
- Principal investigator, Bin Cao, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03545919
- Sponsor's protocol ID
- 2018-20-K15
- Status last verified
- Aug 2018
- First submitted
- 13 May 2018
- Last updated
- 7 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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 Transplantation: Thirty-fourth Adult Lung And Heart-Lung Transplantation Report-2017; Focus Theme: Allograft ischemic time. J Heart Lung Transplant. 2017 Oct;36(10):1047-1059. doi: 10.1016/j.healun.2017.07.016. Epub 2017 Jul 19. No abstract available.
PubMed 28784324Peghin M, Hirsch HH, Len O, Codina G, Berastegui C, Saez B, Sole J, Cabral E, Sole A, Zurbano F, Lopez-Medrano F, Roman A, Gavalda J. Epidemiology and Immediate Indirect Effects of Respiratory Viruses in Lung Transplant Recipients: A 5-Year Prospective Study. Am J Transplant. 2017 May;17(5):1304-1312. doi: 10.1111/ajt.14042. Epub 2016 Oct 14.
PubMed 27615811Bridevaux 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 Jan;69(1):32-8. doi: 10.1136/thoraxjnl-2013-203581. Epub 2013 Sep 11.
PubMed 24025442Seo 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/cid/ciw284. Epub 2016 May 3.
PubMed 27143659Bernasconi 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. Am J Respir Crit Care Med. 2016 Nov 15;194(10):1252-1263. doi: 10.1164/rccm.201512-2424OC.
PubMed 27248293Mouraux 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 transplanted lung. J Allergy Clin Immunol. 2018 Feb;141(2):718-729.e7. doi: 10.1016/j.jaci.2017.06.022. Epub 2017 Jul 18.
PubMed 28729000Willner 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. 2013 Mar 15;187(6):640-7. doi: 10.1164/rccm.201209-1680OC. Epub 2013 Jan 17.
PubMed 23328523Borewicz 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.
PubMed 23173619
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Significance of Community-acquired Respiratory Virus Infection and Longitudinal Analysis of the Lung Microbiome in Lung Transplantation
- ClinicalTrials.gov ID
- NCT03545919
- Acronym / sponsor ID
- 2018-20-K15
- Keywords
- respiratory viral infections, chronic lung allograft dysfunction, lung microbiome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Collaborators
- China-Japan Friendship Hospital, Chinese Academy of Medical Sciences
- Study start
- 5 Aug 2018 (estimated)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 4 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 100 patients with lung transplantation who meet the below inclusion criteria will be recruited in China-Japan Friendship Hospital in Beijing,China.
Key inclusion criteria (1 listed)
- 1.Patients with lung transplantation. 2.The patients who agree to participate in this study and sign informed consent.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The progression rates from upper respiratory tract infection to lower respiratory tract infection within 40 days after diagnosis.
Time frame: 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
Time frame: 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.
Time frame: 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)
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
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
- Results publication: PubMed 28784324Chambers 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 Transplantation: Thirty-fourth Adult Lung And Heart-Lung Transplantation Report-2017; Focus Theme: Allograft ischemic time. J Heart Lung Transplant. 2017 Oct;36(10):1047-1059. doi: 10.1016/j.healun.2017.07.016. Epub 2017 Jul 19. No abstract available.
- Results publication: PubMed 27615811Peghin M, Hirsch HH, Len O, Codina G, Berastegui C, Saez B, Sole J, Cabral E, Sole A, Zurbano F, Lopez-Medrano F, Roman A, Gavalda J. Epidemiology and Immediate Indirect Effects of Respiratory Viruses in Lung Transplant Recipients: A 5-Year Prospective Study. Am J Transplant. 2017 May;17(5):1304-1312. doi: 10.1111/ajt.14042. Epub 2016 Oct 14.
- Results publication: PubMed 24025442Bridevaux 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 Jan;69(1):32-8. doi: 10.1136/thoraxjnl-2013-203581. Epub 2013 Sep 11.
- Results publication: PubMed 27143659Seo 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/cid/ciw284. Epub 2016 May 3.
- Results publication: PubMed 27248293Bernasconi 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. Am J Respir Crit Care Med. 2016 Nov 15;194(10):1252-1263. doi: 10.1164/rccm.201512-2424OC.
- Results publication: PubMed 28729000Mouraux 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 transplanted lung. J Allergy Clin Immunol. 2018 Feb;141(2):718-729.e7. doi: 10.1016/j.jaci.2017.06.022. Epub 2017 Jul 18.
- Results publication: PubMed 23328523Willner 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. 2013 Mar 15;187(6):640-7. doi: 10.1164/rccm.201209-1680OC. Epub 2013 Jan 17.
- Results publication: PubMed 23173619Borewicz 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Transplant Infection and Lung Transplant Rejection, run by Capital Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Si si Du, Ph.D (86 13512916908, dusisi511@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The progression rates from upper respiratory tract infection to lower respiratory tract infection within 40 days after diagnosis. (time frame: 40 days after diagnosis). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03545919, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2018.