NCT00891865

Brief Summary

The purpose of this study is to determine whether respiratory viral infections increase the risk of bronchiolitis obliterans syndrome (BOS), obliterative bronchiolitis (OB), death, or retransplantation in children who have received lung transplants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2009

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
completed

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

April 29, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 1, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

July 2, 2020

Status Verified

June 1, 2020

Enrollment Period

5.8 years

First QC Date

April 29, 2009

Last Update Submit

June 30, 2020

Conditions

Lung TransplantBronchiolitis ObliteransObliterative Bronchiolitis

Keywords

lung transplantBOSOBRespiratory Viral Infection (RVI)Lung disease

Outcome Measures

Primary Outcomes (1)

  • The earliest time to BOS or OB, retransplantation or death

    Within 24 months of transplant

Secondary Outcomes (1)

  • Time to each of the following events: BOS or OB, retransplantation or death

    Within 24 months of transplant

Study Arms (1)

Pediatric lung transplantation

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pediatric patients undergoing lung transplantation

You may qualify if:

  • Parent or legal guardian willing and able to provide informed consent
  • Participant of first single or bilateral heart-lung transplant

You may not qualify if:

  • Recipient of multi-organ transplant (aside from heart-lung)
  • Condition or characteristic which in the opinion of the investigator makes the participant unlikely to complete the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Stanford University

Palo Alto, California, 94305, United States

Location

Children's Hospital Boston

Boston, Massachusetts, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Children's Hospital of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Publications (5)

  • Hayes D Jr, Ballard HO. Saber-sheath trachea in a patient with bronchiolitis obliterans syndrome after lung transplantation. Chron Respir Dis. 2009;6(1):49-52. doi: 10.1177/1479972308099990.

    PMID: 19176714BACKGROUND

  • Sweet SC. Pediatric lung transplantation. Proc Am Thorac Soc. 2009 Jan 15;6(1):122-7. doi: 10.1513/pats.200808-095GO.

    PMID: 19131537BACKGROUND

  • Vos R, Vanaudenaerde BM, De Vleeschauwer SI, Van Raemdonck DE, Dupont LJ, Verbeken EK, De Wever W, Verleden GM. Follicular bronchiolitis: a rare cause of bronchiolitis obliterans syndrome after lung transplantation: a case report. Am J Transplant. 2009 Mar;9(3):644-50. doi: 10.1111/j.1600-6143.2008.02518.x. Epub 2009 Feb 3.

    PMID: 19191770BACKGROUND

  • Yun JJ, Mason DP. Lung transplantation: past, present, and future. Minerva Chir. 2009 Feb;64(1):37-44.

    PMID: 19202534BACKGROUND

  • Sweet SC, Chin H, Conrad C, Hayes D Jr, Heeger PS, Faro A, Goldfarb S, Melicoff-Portillo E, Mohanakumar T, Odim J, Schecter M, Storch GA, Visner G, Williams NM, Kesler K, Danziger-Isakov L. Absence of evidence that respiratory viral infections influence pediatric lung transplantation outcomes: Results of the CTOTC-03 study. Am J Transplant. 2019 Dec;19(12):3284-3298. doi: 10.1111/ajt.15505. Epub 2019 Jul 25.

    PMID: 31216376RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood and nasopharyngeal samples

MeSH Terms

Conditions

Bronchiolitis ObliteransLung Diseases

Condition Hierarchy (Ancestors)

BronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, Obstructive

Study Officials

  • Stuart Sweet, MD, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

  • Lara Danziger-Isakov, MD, MPH

    Children's Hospital Medical Center, Cincinnati

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2009

First Posted

May 1, 2009

Study Start

June 1, 2009

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

July 2, 2020

Record last verified: 2020-06

Locations

US(6)