Clinical trial NCT00891865: Viral Triggers in Pediatric Lung Transplantation
Official title: Viral Triggers of Alloimmunity and Autoimmunity in Pediatric Lung Transplantation (CTOTC-03)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Transplant
Bronchiolitis Obliterans
Obliterative Bronchiolitis
Keywords: lung transplant
BOS
OB
Respiratory Viral Infection (RVI)
Lung disease
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2009-05-01
Enrollment: 61
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients undergoing lung transplantation

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.


Eligibility criteria: 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

Primary outcomes:
measure: The earliest time to BOS or OB, retransplantation or death
timeFrame: Within 24 months of transplant
Secondary outcomes:
measure: Time to each of the following events: BOS or OB, retransplantation or death
timeFrame: Within 24 months of transplant
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Pennsylvania
state: Pennsylvania
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: Washington University School of Medicine
name: Stuart Sweet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital Medical Center, Cincinnati
name: Lara Danziger-Isakov, MD, MPH
role: STUDY_CHAIR
References:
citation: 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.
citation: Sweet SC. Pediatric lung transplantation. Proc Am Thorac Soc. 2009 Jan 15;6(1):122-7. doi: 10.1513/pats.200808-095GO.
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.
citation: Yun JJ, Mason DP. Lung transplantation: past, present, and future. Minerva Chir. 2009 Feb;64(1):37-44.
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 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.