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

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

Recruiting
18 years and younger
All
Phase N/A

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Overview

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 .

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

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.

Study details
    Hematopoietic Cell Transplant
    Solid Organ Transplant
    Respiratory Viral Infection

NCT05550298

Arkansas Children's Hospital Research Institute

17 January 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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