Multi-Center Molecular Diagnosis and Host Response of Respiratory Viral Infections in Pediatric Transplant Recipients
3 other identifiers
observational
2,000
1 country
27
Brief Summary
The participants are being asked to take part in this clinical trial, a type of research study, because the participants are scheduled to receive or have recently received a hematopoietic cell transplant (HCT) or a solid organ transplant (SOT). Primary Objective To determine if pre-transplant screening for respiratory viral load predicts RVI within 1- year post-transplant among survivors. Secondary Objectives:
- To develop and validate a classifier based on pre-transplant immunological profile predictive of developing an acute respiratory viral infection (aRVI), with RSV/PIV3/HMPV/SARS-CoV-2 through one-year post-transplant among survivors.
- To develop and validate a classifier based on Day +100 post-transplant immunological profiles predictive of developing an acute respiratory viral infection (aRVI),with RSV/PIV3/HMPV/SARS-CoV-2 through one-year post-transplant among survivors .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2022
Longer than P75 for all trials
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2022
CompletedFirst Posted
Study publicly available on registry
September 22, 2022
CompletedStudy Start
First participant enrolled
December 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2029
October 2, 2025
January 1, 2025
4.6 years
September 19, 2022
September 29, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of participants developing a RVI within one-year post transplant.
Prevalence is estimated as the proportion of HCT or SOT participants with a positive PCR pre-transplant screen who develop any RVI within one year post transplant. A 95% confidence interval will be provided.
Baseline through 1-year post-transplant
Secondary Outcomes (2)
Predicted risk of a post-transplant recipient developing an aRVI within one-year post-transplant
1 year
Predicted risk of a post-transplant recipient developing an aRVI from Day 100 to one year post transplant.
Day +100 through 1-year post-transplant
Study Arms (2)
Hematopoietic Cell Transplantation (HCT)
Early and accurate diagnosis of respiratory viral infections (RVIs) in children and adolescents who have undergone HCT is important for improving outcomes. The investigators are doing this study to understand more about how RVIs affect children who receive a transplant.
Solid Organ Transplant (SOT)
Early and accurate diagnosis of respiratory viral infections (RVIs) in children and adolescents who have undergone SOT is important for improving outcomes. The investigators are doing this study to understand more about how RVIs affect children who receive a transplant.
Eligibility Criteria
All participants who meet eligibility criteria and consent to enrollment on the study.
You may qualify if:
- Less than 18 years at the time of anticipated transplant
- Participant meets one of the following criteria:
- scheduled to receive allogeneic hematopoietic cell transplant within 14 days of enrollment or
- Scheduled to or received solid organ transplant within 7 days before or after enrollment
- Participant is receiving care at the time of enrollment at one of the study participating institutions.
- Parent/guardian willing and able to provide informed consent, and if appropriate, child willing and able to provide informed assent.
- Donor for HCT recipient enrolled on the VIPER study.
- Willing and able to provide informed consent.
You may not qualify if:
- None
- Is not an HCT donor for a participant enrolled on the VIPER study.
- Not available to provide pre-transplant research blood sample.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
University of Alabama at Birmingham's (UAB)
Birmingham, Alabama, 35294, United States
Arkansas Children's Hospital
Little Rock, Arkansas, 72202, United States
Children's National Medical
Washington D.C., District of Columbia, 20010, United States
University if Miami
Miami, Florida, 33146, United States
Emory and Children's Healthcare of Atlanta
Atlanta, Georgia, 30322, United States
University of Chicago Medicine Comer Children's Hospital
Chicago, Illinois, 60637, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
C.S. Mott Children's Hospital
Ann Arbor, Michigan, 48109, United States
Children's Hospital of Michigan
Detroit, Michigan, 48201, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Washington University
St Louis, Missouri, 63105, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
The Children's Hospital at Montefiore
The Bronx, New York, 10467, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
UPMC
Pittsburgh, Pennsylvania, 15224, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Le Bonheur Children's Hospital
Memphis, Tennessee, 38103, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
UT Le Bonheur
Memphis, Tennessee, 38105, United States
Cook Children's
Fort Worth, Texas, 76104, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
MD Anderson Center Center
Houston, Texas, 77030, United States
UTHealth Houston
Houston, Texas, 77225-0036, United States
Seattle Childrens
Seattle, Washington, 98105, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Gabriela Maron, MD
St. Jude Children's Research Hospital
- PRINCIPAL INVESTIGATOR
William J. Steinbach, MD
Arkansas Children's Hospital Research Institute
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2022
First Posted
September 22, 2022
Study Start
December 13, 2022
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
August 1, 2029
Last Updated
October 2, 2025
Record last verified: 2025-01