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Observational Study on Respiratory Viral Infections in Pediatric Transplant Recipients

This research study is for children up to 18 years old who are scheduled to receive, or have recently received, a hematopoietic cell transplant (HCT, a type of stem cell transplant) or a solid organ transplant. The study aims to understand if screening for respiratory viruses before a transplant can predict if a child will get a respiratory viral infection (RVI) within one year after their transplant. Researchers will collect nasal swabs and blood samples at different times to learn more about these infections. The study is looking to enroll about 2000 participants.

Study design
This is an observational study, meaning researchers will collect information without giving any specific interventions. It plans to enroll about 2000 participants.
What's involved
You would provide a nasal swab and blood sample when you join the study, and again if you develop a respiratory viral infection within the first year after transplant. A blood sample will also be collected 100 days after your transplant.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for one year after their transplant to see if they develop a respiratory viral infection.

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NCT05550298

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

Recruiting
Not specifiedUp to 18Observational
Arkansas Children's Hospital Research Institute
~2,000 participants
Updated 2025-10-02 on ClinicalTrials.gov

At a glance

Recruiting sites
27 of 27 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of participants developing a RVI within one-year post transplant.
Measured over Baseline through 1-year post-transplant

Conditions

Hematopoietic Cell Transplant
Solid Organ Transplant
Respiratory Viral Infection

Explore related trials

Hematopoietic Cell TransplantationSolid organ transplant to recipientViral respiratory infection

Where it's being run

27 sites across 20 states
Texas4
Tennessee3
Michigan2
Ohio2
Alabama1
Arkansas1
District of Columbia1
Florida1

Study leadership

  • Gabriela Maron, MD · PRINCIPAL_INVESTIGATOR · St. Jude Children's Research Hospital
  • William J. Steinbach, MD · PRINCIPAL_INVESTIGATOR · Arkansas Children's Hospital Research Institute

Who to contact

Gabriela Maron, MD
[email protected]
866-278-5833
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Less than 18 years at the time of anticipated transplant
Participant meets one of the following criteria:
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

Is not an HCT donor for a participant enrolled on the VIPER study.
Not available to provide pre-transplant research blood sample.

What this trial measures

  • Proportion of participants developing a RVI within one-year post transplant.Baseline through 1-year post-transplant

    Prevalence is estimated as the proportion of HCT or SOT participants with a positive PCR pre-transplant screen who develop any RVI within one year post transplant. A 95% confidence interval will be provided.