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Hematopoietic Cell TransplantNCT05550298

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

An observational study of Hematopoietic Cell Transplant and Solid Organ Transplant, run by Arkansas Children's Hospital Research Institute at 27 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages Up to 18 years
How many people
2,000 participants
Where
27 sitesUnited States
Study dates
13 Dec 2022to Aug 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: All participants who meet eligibility criteria and consent to enrollment on the study.

Who may be able to join

None listed.

Who cannot join

  • 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.

Trial locations and contacts

27 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Gabriela Maron, MD contact

866-278-5833

referralinfo@stjude.org

William J. Steinbach, MD contact

501-364-5262

wsteinbach@uams.edu

27 sites in 1 country

United States27 sites, 27 recruiting

  • C.S. Mott Children's Hospital

    Ann Arbor, Michigan, 48109

    Jason Weinberg,, MD, 734-764-6265, jbwein@med.umich.edu

    Jason Weinberg,, MD

    Recruiting

  • Emory and Children's Healthcare of Atlanta

    Atlanta, Georgia, 30322

    Kathryn Goggin, MD, 404-785-5437, kathryn.pearl.goggin@emory.edu

    Kathryn Goggin, MD

    Recruiting

  • University of Alabama at Birmingham's (UAB)

    Birmingham, Alabama, 35294

    Maria Rueda Altez, MD, 205-638-2599, mruedaaltez@uabmc.edu

    Maria Rueda Altez, MD

    Recruiting

  • Boston Children's Hospital

    Boston, Massachusetts, 02115

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

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Lauren Powell, DO, 843-792-9909, powellau@musc.edu

    Recruiting

  • University of Chicago Medicine Comer Children's Hospital

    Chicago, Illinois, 60637

    Madan Kumar, MD, 773-702-7087, mkumar@peds.bsd.uchicago.edu

    Madan Kumar

    Recruiting

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

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

    Recruiting

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205

    Masako Shimamura, MD, 614-722-4452

    Masako Shimamura, MD

    Recruiting

  • Children's Hospital of Michigan

    Detroit, Michigan, 48201

    Arora Harbir, MD, 313-745-5219, arora1hs@cmich.edu

    Arora Harbir, MD

    Recruiting

  • Cook Children's

    Fort Worth, Texas, 76104

    marysuzanne.whitworth@cookchildrens.org S. Whitworth, MD, 682-885-1485, marysuzanne.whitworth@cookchildrens.org

    Recruiting

  • Baylor College of Medicine

    Houston, Texas, 77030

    Elizabeth Moulton, MD, 832-824-4330, emoulton@bcm.edu

    Elizabeth Moulton, MD

    Recruiting

  • MD Anderson Center Center

    Houston, Texas, 77030

    Natalie D Garnes, MD, 713-745-0855, njdailey@mdanderson.org

    Jennifer Jackson, 346-725-1272, jrjackson1@mdanderson.org

    Recruiting

  • UTHealth Houston

    Houston, Texas, 77225-0036

    Ramia Zakhour, MD, 713-500-5714, ramia.g.zakhour@uth.tmc.edu

    Ramia Zakhour, MD

    Recruiting

  • Arkansas Children's Hospital

    Little Rock, Arkansas, 72202

    William J. Steinbach, MD, 501-364-5262, wsteinbach@uams.edu

    Recruiting

  • University of Louisville

    Louisville, Kentucky, 40202

    Victoria Statler, MD

    Victoria Statler, MD

    Recruiting

  • Le Bonheur Children's Hospital

    Memphis, Tennessee, 38103

    Timothy Minniear, MD, 901-287-5374, tminniea@uthsc.edu

    Recruiting

  • St. Jude Children's Research Hospital

    Memphis, Tennessee, 38105

    Gabriela Maron, MD, 866-278-5833, referralinfo@stjude.org

    Gabriela Maron, MD

    Recruiting

  • UT Le Bonheur

    Memphis, Tennessee, 38105

    Timothy Minniear, MD, 901-287-5374, tminniea@uthsc.edu

    Recruiting

  • University if Miami

    Miami, Florida, 33146

    Ivan Gonzalez, MD, i.gonzalez2@med.miami.edu

    Ivan Gonzalez, MD

    Recruiting

  • Children's Hospital of Wisconsin

    Milwaukee, Wisconsin, 53226

    Anna Huppler, MD, 414-337-7090, ahuppler@mcw.edu

    Anna Huppler, MD

    Recruiting

  • University of Minnesota

    Minneapolis, Minnesota, 55455

    Beth Thielen, MD., PhD, 612-626-5637, thie0149@umn.edu

    Beth Thielen, MD., PhD

    Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

    Kari Neeman, MD, 402-559-4000, kneemann@unmc.edu

    Kari Neeman, MD

    Recruiting

  • UPMC

    Pittsburgh, Pennsylvania, 15224

    Johnathan Albert, MD, 412-692-3021, albertjd1@upmc.edu

    Isaac Cason, 412-692-7351, casoni@upmc.edu

    Recruiting

  • Seattle Childrens

    Seattle, Washington, 98105

    Alpana Waghmare, MD, 206-987-6558, awaghmar@fredhutch.org

    Recruiting

  • Washington University

    St Louis, Missouri, 63105

    Carol M Kao, MD, 314-273-4687, kaoc@wustl.edu

    Carol M Kao, MD

    Recruiting

  • The Children's Hospital at Montefiore

    The Bronx, New York, 10467

    Marc Foca, MD, 718-741-2470, mfoca@montefiore.org

    Marc Foca, MD

    Recruiting

  • Children's National Medical

    Washington D.C., District of Columbia, 20010

    Benjamin Hanisch, MD, 202-476-5051, Bhanisch@childrensnational.org

    Benjamin Hanisch, MD

    Recruiting

Other trials in United States

About this study

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

Read more

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 .
Read the 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.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05550298
Study groupRoleWhat they receive
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of participants developing a RVI within one-year post transplant.

    Prevalence is estimated as the proportion of HCT or SOT participants with a positive PCR pre-transplant screen who develop any RVI within one year post transplant. A 95% confidence interval will be provided.

    Measured: Baseline through 1-year post-transplant

Secondary outcomes (2)

  1. Predicted risk of a post-transplant recipient developing an aRVI within one-year post-transplant

    Risk will be predicted by the development of a pre-transplant immunology model utilizing measurements of pre-transplant quantitative immunology (recipient and donor) and RSV/PIV3/HMPV/SARS-CoV-2 RVI from pre-transplant to year one post-transplant

    Measured: 1 year

  2. Predicted risk of a post-transplant recipient developing an aRVI from Day 100 to one year post transplant.

    Risk will be predicted by the development of a pre-transplant immunology model utilizing measurements of Day 100 quantitative immunology (recipient and donor) and RSV/PIV3/HMPV/SARS-CoV-2 RVI from Day 100 to year one post-transplant

    Measured: Day +100 through 1-year post-transplant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2022
  2. Study start13 Dec 2022
  3. Primary completionAug 2027 (estimated)
  4. Study completionAug 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05550298
Sponsor's protocol ID
VIPER
Other IDs
7R01AI159684-02, NCI-2022-08554
Status last verified
Jan 2025
First submitted
19 Sep 2022
Last updated
2 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Hematopoietic Cell Transplant and Solid Organ Transplant, run by Arkansas Children's Hospital Research Institute at 27 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gabriela Maron, MD (866-278-5833, referralinfo@stjude.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants developing a RVI within one-year post transplant. (time frame: Baseline through 1-year post-transplant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05550298.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.

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