Actively Recruiting

Age: 0 - 18Years
All Genders
ID05550298

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

104 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

This research focuses on pediatric patients scheduled to receive or who have recently received a hematopoietic cell transplant (HCT) or a solid organ transplant (SOT). It aims to investigate whether screening for respiratory viral load before transplant can predict respiratory viral infections (RVI) within one year after transplant. The study also seeks to develop and validate immune response profiles to predict acute respiratory viral infections caused by viruses such as RSV, PIV3, HMPV, and SARS-CoV-2 during the first year post-transplant. Participants will have nasal swabs and blood samples collected at enrollment, and additional blood samples taken 100 days after transplant. These samples will be used to analyze molecular diagnostics and immune responses related to respiratory viral infections. The study includes two groups: children undergoing hematopoietic cell transplantation and those undergoing solid organ transplantation, with the goal of understanding how RVIs affect these pediatric transplant recipients. Throughout the study, researchers will monitor the occurrence of respiratory viral infections for one year following transplant. They will evaluate clinical data alongside laboratory tests such as blood and nasal swab analyses. The primary measurement is the proportion of participants developing an RVI within one year post-transplant. Secondary measures include the predicted risk of acute respiratory viral infections within this timeframe. Participants and their guardians will provide consent and assent as appropriate, and the study spans from enrollment through a full year after transplant.

CONDITIONS

Brief 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...

  • Less than 18 years old at the time of anticipated transplant
  • 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
  • Receiving care at one of the study participating institutions at the time of enrollment
  • Parent or guardian willing and able to provide informed consent
  • Child willing and able to provide informed assent, if appropriate
  • Donor for hematopoietic cell transplant recipient enrolled on the study
  • Donor willing and able to provide informed consent
Not Eligible

You will not qualify if you...

  • Donor is not an HCT donor for a participant enrolled on the study
  • Donor not available to provide pre-transplant research blood sample

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - Up to 2 weeks before transplant

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surveillance

Duration - Up to 1 year post-transplant

Participants are observed to detect respiratory viral infections within the first year after transplant.

Visits occur if respiratory viral infection develops; blood samples collected around Day 100 post-transplant

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

W

William J. Steinbach, MD

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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