NCT05550298 Multi-Center Molecular Diagnosis and Host Response of Respiratory Viral Infections in Pediatric Transplant Recipients
| NCT ID | NCT05550298 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Arkansas Children's Hospital Research Institute |
| Condition | Hematopoietic Cell Transplant |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2022-12-13 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,000 participants in total. It began in 2022-12-13 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Gabriela Maron, MD
PRINCIPAL INVESTIGATOR
St. Jude Children's Research Hospital
Frequently Asked Questions
Who can join the NCT05550298 clinical trial?
This trial is open to participants of all sexes, up to 18 Years, studying Hematopoietic Cell Transplant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05550298 currently recruiting?
Yes, NCT05550298 is actively recruiting participants. Contact the research team at referralinfo@stjude.org for enrollment information.
Where is the NCT05550298 trial being conducted?
This trial is being conducted at Birmingham, United States, Little Rock, United States, Washington D.C., United States, Miami, United States and 11 additional locations.
Who is sponsoring the NCT05550298 clinical trial?
NCT05550298 is sponsored by Arkansas Children's Hospital Research Institute. The principal investigator is Gabriela Maron, MD at St. Jude Children's Research Hospital. The trial plans to enroll 2,000 participants.