Actively Recruiting

Age: 0 - 18Years
All Genders
NCT05550298

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

Led by Arkansas Children's Hospital Research Institute · Updated on 2025-10-02

2000

Participants Needed

27

Research Sites

346 weeks

Total Duration

On this page

Sponsors

A

Arkansas Children's Hospital Research Institute

Lead Sponsor

S

St. Jude Children's Research Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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 .

CONDITIONS

Official Title

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

Who Can Participate

Age: 0 - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

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.
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 27 locations

1

University of Alabama at Birmingham's (UAB)

Birmingham, Alabama, United States, 35294

Actively Recruiting

2

Arkansas Children's Hospital

Little Rock, Arkansas, United States, 72202

Actively Recruiting

3

Children's National Medical

Washington D.C., District of Columbia, United States, 20010

Actively Recruiting

4

University if Miami

Miami, Florida, United States, 33146

Actively Recruiting

5

Emory and Children's Healthcare of Atlanta

Atlanta, Georgia, United States, 30322

Actively Recruiting

6

University of Chicago Medicine Comer Children's Hospital

Chicago, Illinois, United States, 60637

Actively Recruiting

7

University of Louisville

Louisville, Kentucky, United States, 40202

Actively Recruiting

8

Boston Children's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

9

C.S. Mott Children's Hospital

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

10

Children's Hospital of Michigan

Detroit, Michigan, United States, 48201

Actively Recruiting

11

University of Minnesota

Minneapolis, Minnesota, United States, 55455

Actively Recruiting

12

Washington University

St Louis, Missouri, United States, 63105

Actively Recruiting

13

University of Nebraska Medical Center

Omaha, Nebraska, United States, 68198

Actively Recruiting

14

The Children's Hospital at Montefiore

The Bronx, New York, United States, 10467

Actively Recruiting

15

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229

Actively Recruiting

16

Nationwide Children's Hospital

Columbus, Ohio, United States, 43205

Actively Recruiting

17

UPMC

Pittsburgh, Pennsylvania, United States, 15224

Actively Recruiting

18

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

Actively Recruiting

19

Le Bonheur Children's Hospital

Memphis, Tennessee, United States, 38103

Actively Recruiting

20

St. Jude Children's Research Hospital

Memphis, Tennessee, United States, 38105

Actively Recruiting

21

UT Le Bonheur

Memphis, Tennessee, United States, 38105

Actively Recruiting

22

Cook Children's

Fort Worth, Texas, United States, 76104

Actively Recruiting

23

Baylor College of Medicine

Houston, Texas, United States, 77030

Actively Recruiting

24

MD Anderson Center Center

Houston, Texas, United States, 77030

Actively Recruiting

25

UTHealth Houston

Houston, Texas, United States, 77225-0036

Actively Recruiting

26

Seattle Childrens

Seattle, Washington, United States, 98105

Actively Recruiting

27

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

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Research Team

G

Gabriela Maron, MD

CONTACT

W

William J. Steinbach, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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