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NCT05550298Recruiting

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

Arkansas Children's Hospital Research Institute

Start Date

12/13/2022

Completion Date

8/1/2029

Summary

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.

Eligibility Criteria

Age Range: No minimum to 18 years

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.

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Conditions

Hematopoietic Cell TransplantSolid Organ TransplantRespiratory Viral Infection

Locations

University of Alabama at Birmingham's (UAB)

Birmingham, Alabama 35294

United States

Arkansas Children's Hospital

Little Rock, Arkansas 72202

United States

Children's National Medical

Washington D.C., District of Columbia 20010

United States

University if Miami

Miami, Florida 33146

United States

Emory and Children's Healthcare of Atlanta

Atlanta, Georgia 30322

United States

University of Chicago Medicine Comer Children's Hospital

Chicago, Illinois 60637

United States

University of Louisville

Louisville, Kentucky 40202

United States

Boston Children's Hospital

Boston, Massachusetts 02115

United States

C.S. Mott Children's Hospital

Ann Arbor, Michigan 48109

United States

Children's Hospital of Michigan

Detroit, Michigan 48201

United States

University of Minnesota

Minneapolis, Minnesota 55455

United States

Washington University

St Louis, Missouri 63105

United States

University of Nebraska Medical Center

Omaha, Nebraska 68198

United States

The Children's Hospital at Montefiore

The Bronx, New York 10467

United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio 45229

United States

Nationwide Children's Hospital

Columbus, Ohio 43205

United States

UPMC

Pittsburgh, Pennsylvania 15224

United States

Medical University of South Carolina

Charleston, South Carolina 29425

United States

Le Bonheur Children's Hospital

Memphis, Tennessee 38103

United States

St. Jude Children's Research Hospital

Memphis, Tennessee 38105

United States

UT Le Bonheur

Memphis, Tennessee 38105

United States

Cook Children's

Fort Worth, Texas 76104

United States

Baylor College of Medicine

Houston, Texas 77030

United States

MD Anderson Center Center

Houston, Texas 77030

United States

UTHealth Houston

Houston, Texas 77225-0036

United States

Seattle Childrens

Seattle, Washington 98105

United States

Children's Hospital of Wisconsin

Milwaukee, Wisconsin 53226

United States