NCT03545919

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 4, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

August 5, 2018

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

August 7, 2018

Status Verified

August 1, 2018

Enrollment Period

3.8 years

First QC Date

May 13, 2018

Last Update Submit

August 5, 2018

Conditions

Lung Transplant InfectionLung Transplant Rejection

Keywords

respiratory viral infectionschronic lung allograft dysfunctionlung microbiome

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

100 patients with lung transplantation who meet the below inclusion criteria will be recruited in China-Japan Friendship Hospital in Beijing,China.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China-Japan Friendship Hospital

Beijing, 100029, China

RECRUITING

Related Publications (8)

  • 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.

    PMID: 28784324RESULT

  • Peghin 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.

    PMID: 27615811RESULT

  • 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 Jan;69(1):32-8. doi: 10.1136/thoraxjnl-2013-203581. Epub 2013 Sep 11.

    PMID: 24025442RESULT

  • 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/cid/ciw284. Epub 2016 May 3.

    PMID: 27143659RESULT

  • 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. Am J Respir Crit Care Med. 2016 Nov 15;194(10):1252-1263. doi: 10.1164/rccm.201512-2424OC.

    PMID: 27248293RESULT

  • 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 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.

    PMID: 28729000RESULT

  • 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. 2013 Mar 15;187(6):640-7. doi: 10.1164/rccm.201209-1680OC. Epub 2013 Jan 17.

    PMID: 23328523RESULT

  • 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.

    PMID: 23173619RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood Bronchoalveolar lavage fluid

Central Study Contacts

Si si Du, Ph.D

CONTACT

86 13512916908dusisi511@126.com

Bin Cao, MD

CONTACT

86-010-84206264caobin_ben@163.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor of Medicine

Study Record Dates

First Submitted

May 13, 2018

First Posted

June 4, 2018

Study Start

August 5, 2018

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

August 7, 2018

Record last verified: 2018-08

Locations

CN(1)