Viral Triggers in Pediatric Lung Transplantation

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00891865
First received: April 29, 2009
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

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
Lung Transplant
Bronchiolitis Obliterans
Obliterative Bronchiolitis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Viral Triggers of Alloimmunity and Autoimmunity in Pediatric Lung Transplantation (CTOTC-03)

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • The earliest time to BOS or OB, retransplantation or death [ Time Frame: Within 24 months of transplant ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to each of the following events: BOS or OB, retransplantation or death [ Time Frame: Within 24 months of transplant ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

Blood and nasopharyngeal samples


Enrollment: 61
Study Start Date: June 2009
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pediatric lung transplantation

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pediatric patients undergoing lung transplantation

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00891865

Locations
United States, California
Stanford University
Palo Alto, California, United States, 94305
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States
United States, Missouri
Washington University
St.Louis, Missouri, United States, 63110
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
United States, Pennsylvania
Children's Hospital of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
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
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00891865     History of Changes
Other Study ID Numbers: DAIT CTOTC-03
Study First Received: April 29, 2009
Last Updated: February 11, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
lung transplant
BOS
OB
Respiratory Viral Infection (RVI)
Lung disease

Additional relevant MeSH terms:
Bronchiolitis
Bronchiolitis Obliterans
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on September 18, 2014