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Recruiting NCT05550298

Multi-Center Molecular Diagnosis and Host Response of Respiratory Viral Infections in Pediatric Transplant Recipients

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Trial Parameters

Condition Hematopoietic Cell Transplant
Sponsor Arkansas Children's Hospital Research Institute
Study Type OBSERVATIONAL
Phase N/A
Enrollment 2,000
Sex ALL
Min Age N/A
Max Age 18 Years
Start Date 2022-12-13
Completion 2027-08

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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 .

Eligibility Criteria

Recipient Inclusion Criteria * Less than 18 years at the time of anticipated transplant * Participant meets one of the following criteria: 1. scheduled to receive allogeneic hematopoietic cell transplant within 14 days of enrollment or 2. 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 Inclusion Criteria * Donor for HCT recipient enrolled on the VIPER study. * Willing and able to provide informed consent. Exclusion Criteria: 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.

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