Viral Triggers in Pediatric Lung Transplantation

NCT ID: NCT00891865

Last Updated: 2020-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

61 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2015-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Transplant Bronchiolitis Obliterans Obliterative Bronchiolitis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Pediatric lung transplantation

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stuart Sweet, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Lara Danziger-Isakov, MD, MPH

Role: STUDY_CHAIR

Children's Hospital Medical Center, Cincinnati

Locations

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Stanford University

Palo Alto, California, United States

Site Status

Children's Hospital Boston

Boston, Massachusetts, United States

Site Status

Washington University

St Louis, Missouri, United States

Site Status

Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Children's Hospital of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Texas Children's Hospital

Houston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 19176714 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 19131537 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19191770 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 19202534 (View on PubMed)

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.

Reference Type RESULT
PMID: 31216376 (View on PubMed)

Other Identifiers

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DAIT CTOTC-03

Identifier Type: -

Identifier Source: org_study_id

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