Recruiting

Observational Study

Sponsor:

Arkansas Children's Hospital Research Institute

Code:

NCT05550298

Conditions

Hematopoietic Cell Transplant

Solid Organ Transplant

Respiratory Viral Infection

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Study Details

Brief 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 .

Conditions

Hematopoietic Cell Transplant

Solid Organ Transplant

Respiratory Viral Infection

Study ID

NCT05550298

Start date

Dec 13, 2022

Status verified date

Jan, 2025

Completion date

Aug, 2029

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Arms

Hematopoietic Cell Transplantation (HCT)

Early and accurate diagnosis of respiratory viral infections (RVIs) in children and adolescents who have undergone HCT is important for improving outcomes. The investigators are doing this study to understand more about how RVIs affect children who receive a transplant.

Solid Organ Transplant (SOT)

Early and accurate diagnosis of respiratory viral infections (RVIs) in children and adolescents who have undergone SOT is important for improving outcomes. The investigators are doing this study to understand more about how RVIs affect children who receive a transplant.

Primary outcome measure

  • Proportion of participants developing a RVI within one-year post transplant. [ Time Frame: Baseline through 1-year post-transplant ]

Central Contacts and Locations

Central contacts

Gabriela Maron, MD

866-278-5833referralinfo@stjude.org

William J. Steinbach, MD

501-364-5262wsteinbach@uams.edu

Locations

University of Alabama at Birmingham's (UAB)

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Maria Rueda Altez, MD

205-638-2599mruedaaltez@uabmc.edu

Principal Investigator:

Maria Rueda Altez, MD

Arkansas Children's Hospital

Recruiting

Little Rock, Arkansas, United States, 72202

Contacts

William J. Steinbach, MD

501-364-5262wsteinbach@uams.edu

Children's National Medical

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Benjamin Hanisch, MD

202-476-5051Bhanisch@childrensnational.org

Principal Investigator:

Benjamin Hanisch, MD

University if Miami

Recruiting

Miami, Florida, United States, 33146

Contacts

Ivan Gonzalez, MD

i.gonzalez2@med.miami.edu

Principal Investigator:

Ivan Gonzalez, MD

Emory and Children's Healthcare of Atlanta

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Kathryn Goggin, MD

404-785-5437kathryn.pearl.goggin@emory.edu

Principal Investigator:

Kathryn Goggin, MD

University of Chicago Medicine Comer Children's Hospital

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Madan Kumar, MD

773-702-7087mkumar@peds.bsd.uchicago.edu

Principal Investigator:

Madan Kumar

University of Louisville

Recruiting

Louisville, Kentucky, United States, 40202

Principal Investigator:

Victoria Statler, MD

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Tanvi Sharma, MD

617-919-2900Tanvi.Sharma@childrens.harvard.edu

C.S. Mott Children's Hospital

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Jason Weinberg,, MD

734-764-6265jbwein@med.umich.edu

Principal Investigator:

Jason Weinberg,, MD

Children's Hospital of Michigan

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Arora Harbir, MD

313-745-5219arora1hs@cmich.edu

Principal Investigator:

Arora Harbir, MD

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Beth Thielen, MD., PhD

612-626-5637thie0149@umn.edu

Principal Investigator:

Beth Thielen, MD., PhD

Washington University

Recruiting

St Louis, Missouri, United States, 63105

Contacts

Carol M Kao, MD

314-273-4687kaoc@wustl.edu

Principal Investigator:

Carol M Kao, MD

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Contacts

Kari Neeman, MD

402-559-4000kneemann@unmc.edu

Principal Investigator:

Kari Neeman, MD

The Children's Hospital at Montefiore

Recruiting

The Bronx, New York, United States, 10467

Contacts

Marc Foca, MD

718-741-2470mfoca@montefiore.org

Principal Investigator:

Marc Foca, MD

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Lara Danziger-Isakov, MD

513-636-7499Lara.Danziger-Isakov@cchmc.org

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Masako Shimamura, MD

614-722-4452

Principal Investigator:

Masako Shimamura, MD

UPMC

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Johnathan Albert, MD

412-692-3021albertjd1@upmc.edu

Isaac Cason

412-692-7351casoni@upmc.edu

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Lauren Powell, DO

843-792-9909powellau@musc.edu

Le Bonheur Children's Hospital

Recruiting

Memphis, Tennessee, United States, 38103

Contacts

Timothy Minniear, MD

901-287-5374tminniea@uthsc.edu

St. Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

Gabriela Maron, MD

866-278-5833referralinfo@stjude.org

Principal Investigator:

Gabriela Maron, MD

UT Le Bonheur

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

Timothy Minniear, MD

901-287-5374tminniea@uthsc.edu

Cook Children's

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

marysuzanne.whitworth@cookchildrens.org S. Whitworth, MD

682-885-1485marysuzanne.whitworth@cookchildrens.org

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Elizabeth Moulton, MD

832-824-4330emoulton@bcm.edu

Principal Investigator:

Elizabeth Moulton, MD

MD Anderson Center Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Natalie D Garnes, MD

713-745-0855njdailey@mdanderson.org

Jennifer Jackson

346-725-1272jrjackson1@mdanderson.org

Principal Investigator:

Natalie D Garnes, MD

UTHealth Houston

Recruiting

Houston, Texas, United States, 77225-0036

Contacts

Ramia Zakhour, MD

713-500-5714ramia.g.zakhour@uth.tmc.edu

Principal Investigator:

Ramia Zakhour, MD

Seattle Childrens

Recruiting

Seattle, Washington, United States, 98105

Contacts

Alpana Waghmare, MD

206-987-6558awaghmar@fredhutch.org

Children's Hospital of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Anna Huppler, MD

414-337-7090ahuppler@mcw.edu

Principal Investigator:

Anna Huppler, MD

More Information

Sponsor

Arkansas Children's Hospital Research Institute

Last update posted

Oct 2, 2025

Last verified

Jan, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Arkansas Children's Hospital Research Institute on 2025-10-02.