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Recruiting NCT05550298

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

— Observational Hematopoietic Cell Transplant Solid Organ Transplant Respiratory Viral Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Hematopoietic Cell Transplant, Solid Organ Transplant, Respiratory Viral Infection. Basic parameters: up to 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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 .

Detailed 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.

Primary outcome measures

  • Proportion of participants developing a RVI within one-year post transplant. [Time frame: Baseline through 1-year post-transplant]
Secondary outcome measures (2)
  • Predicted risk of a post-transplant recipient developing an aRVI within one-year post-transplant [Time frame: 1 year]
  • Predicted risk of a post-transplant recipient developing an aRVI from Day 100 to one year post transplant. [Time frame: Day +100 through 1-year post-transplant]

Eligibility criteria

Recipient Inclusion Criteria

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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 27 centers
  • University of Alabama at Birmingham's (UAB) — Birmingham
  • Arkansas Children's Hospital — Little Rock
  • Children's National Medical — Washington D.C.
  • University if Miami — Miami
  • Emory and Children's Healthcare of Atlanta — Atlanta
  • University of Chicago Medicine Comer Children's Hospital — Chicago
  • University of Louisville — Louisville
  • Boston Children's Hospital — Boston
  • … and 19 more centers

Identifiers

NCT: NCT05550298 · VIPER · 7R01AI159684-02 · NCI-2022-08554

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗