Clinical Trials Study
N/A
Multi-Center Molecular Diagnosis and Host Response of Respiratory Viral Infections in Pediatric Transplant Recipients
Conditions: Hematopoietic Cell Transplant, Solid Organ Transplant, Respiratory Viral Infection
- Study #:
- NCT05550298
- Last Updated:
- 10/02/2025
- Recruitment Status:
- Recruiting
- Estimated Study Completion Date:
- 08/01/2029
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 .
Age: Newborn to 18 Years old
Gender: All
Start Date: 12/13/2022
Primary Completion Date (Estimated): 08/01/2027
Study Completion Date (Estimated): 08/01/2029
Accepts Healthy Volunteers: No
Trial Purpose and 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.
Eligibility Criteria
Age: Newborn to 18 Years old
Gender: All
Accepts Healthy Volunteers: No
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.
Principal Investigator
Betsy Herold, MD