Multi-Center Molecular Diagnosis and Host Response of Respiratory Viral Infections in Pediatric Transplant Recipients
- Conditions
- Solid Organ TransplantRespiratory Viral InfectionHematopoietic Cell Transplant
- Registration Number
- NCT05550298
- Lead Sponsor
- St. Jude Children's Research Hospital
- 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 .
- Detailed Description
The investigators will collect a nasal swab and blood sample from the participant when the participant is enrolled on the study and if the participant develops a RVI in the first year after transplant. The investigators will collect a blood sample 100 days after the participant's transplant.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2000
Not provided
Recipient Exclusion Criteria
None
Donor Exclusion Criteria
- Is not an HCT donor for a participant enrolled on the VIPER study.
- Not available to provide pre-transplant research blood sample.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of participants developing a RVI within one-year post transplant. Baseline through 1-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.
- Secondary Outcome Measures
Name Time Method Predicted risk of a post-transplant recipient developing an aRVI within one-year post-transplant 1 year Risk will be predicted by the development of a pre-transplant immunology model utilizing measurements of pre-transplant quantitative immunology (recipient and donor) and RSV/PIV3/HMPV/SARS-CoV-2 RVI from pre-transplant to year one post-transplant
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 Risk will be predicted by the development of a pre-transplant immunology model utilizing measurements of Day 100 quantitative immunology (recipient and donor) and RSV/PIV3/HMPV/SARS-CoV-2 RVI from Day 100 to year one post-transplant
Trial Locations
- Locations (27)
University of Louisville
🇺🇸Louisville, Kentucky, United States
University of Alabama at Birmingham's (UAB)
🇺🇸Birmingham, Alabama, United States
Arkansas Children's Hospital
🇺🇸Little Rock, Arkansas, United States
Children's National Medical
🇺🇸Washington, District of Columbia, United States
University if Miami
🇺🇸Miami, Florida, United States
Emory and Children's Healthcare of Atlanta
🇺🇸Atlanta, Georgia, United States
University of Chicago Medicine Comer Children's Hospital
🇺🇸Chicago, Illinois, United States
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
C.S. Mott Children's Hospital
🇺🇸Ann Arbor, Michigan, United States
Children's Hospital of Michigan
🇺🇸Detroit, Michigan, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
The Children's Hospital at Montefiore
🇺🇸Bronx, New York, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Le Bonheur Children's Hospital
🇺🇸Memphis, Tennessee, United States
St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
UT Le Bonheur
🇺🇸Memphis, Tennessee, United States
Cook Children's
🇺🇸Fort Worth, Texas, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
MD Anderson Center Center
🇺🇸Houston, Texas, United States
UTHealth Houston
🇺🇸Houston, Texas, United States
Seattle Childrens
🇺🇸Seattle, Washington, United States
Children's Hospital of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States