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

Save

Report Abuse

Description

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 .

Study Overview

Start Date
December 13, 2022
Completion Date
August 1, 2029
Enrollment
2000
Date Posted
September 22, 2022
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
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, District of Columbia 20010, 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

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
Saint Louis, Missouri 63105, United States

The Children's Hospital at Montefiore
Bronx, New York 10467, United States

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229, United States

UPMC
Pittsburgh, Pennsylvania 15224, 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

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

Eligibility

Study Population
All participants who meet eligibility criteria and consent to enrollment on the study.
Maximum Age (years)
18
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.

Study Contact Info

Study Contact Name
Gabriela Maron, MD; William J. Steinbach, MD
Study Contact Phone

Contact Listings Owner Form

Multi-Center Molecular Diagnosis and Host Response of Respiratory Viral Infections in Pediatric Transplant Recipients 0 reviews

Write Your Review

There are no reviews yet.

Write Your Review

Your email address will not be published. Required fields are marked *

Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
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.
NCTid (if applicable)
NCT05550298