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

Conditions

• Hematopoietic Cell Transplant
• Respiratory Viral Infection
• Solid Organ Transplant

Eligibility Criteria

Sex

ALL

Age

N/A - 18 Years

Healthy Volunteers

Not accepted

Study Details

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 .

Key Dates

Start date

Dec 13, 2022

Status verified

Jan 2025

Primary completion

Aug 31, 2027

Completion

Aug 31, 2029

Study Design

Enrollment

2,000 participants (estimated)

Arms

• Arm: 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.
• Arm: 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

• Gabriela Maron, MD
  866-278-5833
  [email protected]
• William J. Steinbach, MD
  501-364-5262
  [email protected]

Locations (27)

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