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

Arkansas Children's Hospital Research Institute2,000 enrolled

Overview

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 .

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.

Study Type

OBSERVATIONAL

Enrollment

2,000

Conditions

Hematopoietic Cell Transplant Solid Organ Transplant Respiratory Viral Infection

Eligibility

Medical Language ↔ Plain English

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.

Locations (27)

University of Alabama at Birmingham's (UAB)

Birmingham, Alabama, United States

RECRUITING

Arkansas Children's Hospital

Little Rock, Arkansas, United States

RECRUITING

Children's National Medical

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

RECRUITING

University if Miami

Miami, Florida, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline through 1-year post-transplant

Secondary Outcomes

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

Time frame: 1 year

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

Time frame: Day +100 through 1-year post-transplant

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

Overview

Conditions

Eligibility

Locations (27)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts