Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - Up to 2 weeks before transplant
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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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