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

Last updated: January 6, 2025
Sponsor: Arkansas Children's Hospital Research Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stem Cell Transplant

Treatment

N/A

Clinical Study ID

NCT05550298
VIPER
NCI-2022-08554
7R01AI159684-02
  • Ages < 18
  • All Genders

Study 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 .

Eligibility Criteria

Inclusion

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 ofenrollment or

  2. Scheduled to or received solid organ transplant within 7 days before or afterenrollment

  • Participant is receiving care at the time of enrollment at one of the studyparticipating 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

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 Design

Total Participants: 2000
Study Start date:
December 13, 2022
Estimated Completion Date:
August 31, 2029

Study 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.

Connect with a study center

  • University of Alabama at Birmingham's (UAB)

    Birmingham, Alabama 35294
    United States

    Active - Recruiting

  • Arkansas Children's Hospital

    Little Rock, Arkansas 72202
    United States

    Active - Recruiting

  • Children's National Medical

    Washington, District of Columbia 20010
    United States

    Active - Recruiting

  • University if Miami

    Miami, Florida 33146
    United States

    Active - Recruiting

  • Emory and Children's Healthcare of Atlanta

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • University of Chicago Medicine Comer Children's Hospital

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • University of Louisville

    Louisville, Kentucky 40202
    United States

    Active - Recruiting

  • Boston Children's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • C.S. Mott Children's Hospital

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • Children's Hospital of Michigan

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Active - Recruiting

  • Washington University

    Saint Louis, Missouri 63105
    United States

    Active - Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska 68198
    United States

    Active - Recruiting

  • The Children's Hospital at Montefiore

    Bronx, New York 10467
    United States

    Active - Recruiting

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Active - Recruiting

  • Nationwide Children's Hospital

    Columbus, Ohio 43205
    United States

    Active - Recruiting

  • UPMC

    Pittsburgh, Pennsylvania 15224
    United States

    Active - Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • Le Bonheur Children's Hospital

    Memphis, Tennessee 38103
    United States

    Active - Recruiting

  • St. Jude Children's Research Hospital

    Memphis, Tennessee 38105
    United States

    Active - Recruiting

  • UT Le Bonheur

    Memphis, Tennessee 38105
    United States

    Active - Recruiting

  • Cook Children's

    Fort Worth, Texas 76104
    United States

    Active - Recruiting

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Active - Recruiting

  • MD Anderson Center Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • UTHealth Houston

    Houston, Texas 77225-0036
    United States

    Active - Recruiting

  • Seattle Childrens

    Seattle, Washington 98105
    United States

    Active - Recruiting

  • Children's Hospital of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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