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NCT00891865 Clinical Trial

Viral Triggers in Pediatric Lung Transplantation

Bronchiolitis Obliterans Clinical Trial

Official title:
Viral Triggers of Alloimmunity and Autoimmunity in Pediatric Lung Transplantation (CTOTC-03)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00891865
Other study ID # DAIT CTOTC-03
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2009
Est. completion date April 2015

Study information
Verified date June 2020
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 61
Est. completion date April 2015
Est. primary completion date April 2015
Accepts healthy volunteers No
Gender All
Age group N/A to 21 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Children's Hospital Boston Boston Massachusetts
United States Nationwide Children's Hospital Columbus Ohio
United States Texas Children's Hospital Houston Texas
United States Stanford University Palo Alto California
United States Children's Hospital of Pennsylvania Philadelphia Pennsylvania
United States Washington University Saint Louis Missouri

Sponsors (2)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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 p — View Citation

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

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. — View Citation

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

Outcome
Type Measure Description Time frame Safety issue
Primary The earliest time to BOS or OB, retransplantation or death Within 24 months of transplant
Secondary Time to each of the following events: BOS or OB, retransplantation or death Within 24 months of transplant
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Active, not recruiting NCT03656926 - Efficacy + Safety of Liposome Cyclosporine A to Treat Bronchiolitis Obliterans Post Single Lung Transplant (BOSTON-2) Phase 3