Viral Triggers in Pediatric Lung Transplantation
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Overall Status
Completed
CT.gov ID
NCT00891865
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
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70
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Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
61 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Viral Triggers of Alloimmunity and Autoimmunity in Pediatric Lung Transplantation (CTOTC-03)
Study Start Date
:
Jun 1, 2009
Actual Primary Completion Date
:
Apr 1, 2015
Actual Study Completion Date
:
Apr 1, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Pediatric lung transplantation
|
Outcome Measures
Primary Outcome Measures
- The earliest time to BOS or OB, retransplantation or death [Within 24 months of transplant]
Secondary Outcome Measures
- Time to each of the following events: BOS or OB, retransplantation or death [Within 24 months of transplant]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
to 21 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Stanford University | Palo Alto | California | United States | 94305 |
| 2 | Children's Hospital Boston | Boston | Massachusetts | United States | |
| 3 | Washington University | Saint Louis | Missouri | United States | 63110 |
| 4 | Nationwide Children's Hospital | Columbus | Ohio | United States | 43205 |
| 5 | Children's Hospital of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
| 6 | Texas Children's Hospital | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Heart, Lung, and Blood Institute (NHLBI)
Investigators
- Principal Investigator: Stuart Sweet, MD, PhD, Washington University School of Medicine
- Study Chair: Lara Danziger-Isakov, MD, MPH, Children's Hospital Medical Center, Cincinnati
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- Sweet SC. Pediatric lung transplantation. Proc Am Thorac Soc. 2009 Jan 15;6(1):122-7. doi: 10.1513/pats.200808-095GO. Review.
- 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.
- Yun JJ, Mason DP. Lung transplantation: past, present, and future. Minerva Chir. 2009 Feb;64(1):37-44. Review.
Responsible Party:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00891865
Other Study ID Numbers:
- DAIT CTOTC-03
First Posted:
May 1, 2009
Last Update Posted:
Jul 2, 2020
Last Verified:
Jun 1, 2020
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID)
Additional relevant MeSH terms: