We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Viral Triggers in Pediatric Lung Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00891865
Recruitment Status : Completed
First Posted : May 1, 2009
Last Update Posted : May 27, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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
Lung Transplant Bronchiolitis Obliterans Obliterative Bronchiolitis

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 : June 2009
Primary Completion Date : April 2015
Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Pediatric lung transplantation


Outcome Measures

Primary Outcome Measures :
  1. The earliest time to BOS or OB, retransplantation or death [ Time Frame: Within 24 months of transplant ]

Secondary Outcome Measures :
  1. Time to each of the following events: BOS or OB, retransplantation or death [ Time Frame: Within 24 months of transplant ]

Biospecimen Retention:   Samples With DNA
Blood and nasopharyngeal samples

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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
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
First Posted: May 1, 2009    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015

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