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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 18
SponsorArkansas Children's Hospital Research Institute

About this trial

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

Qualifiers

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.

Disqualifiers

Is not an HCT donor for a participant enrolled on the VIPER study.

Not available to provide pre-transplant research blood sample.

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

2,000 Participants
are grouped into 2 trial groups

Sponsors and collaborators

Arkansas Children's Hospital Research Institute

Lead sponsor

St. Jude Children's Research Hospital

Collaborator

Seattle Children's Hospital

Collaborator

Children's Hospital at Montefiore

Collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator