Multi-Center Molecular Diagnosis and Host Response of Respiratory Viral Infections in Pediatric Transplant Recipients
Arkansas Children's Hospital Research Institute
2,000 participants
Dec 13, 2022
OBSERVATIONAL
Conditions
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 .
Eligibility
Inclusion Criteria8
- 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.
Exclusion Criteria3
- None
- Is not an HCT donor for a participant enrolled on the VIPER study.
- Not available to provide pre-transplant research blood sample.
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Locations(27)
View Full Details on ClinicalTrials.gov
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NCT05550298