Clinical trial NCT05550298: Multi-Center Molecular Diagnosis and Host Response of Respiratory Viral Infections in Pediatric Transplant Recipients
Official title: Multi-Center Molecular Diagnosis and Host Response of Respiratory Viral Infections in Pediatric Transplant Recipients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hematopoietic Cell Transplant
Solid Organ Transplant
Respiratory Viral Infection
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: St. Jude Children's Research Hospital
name: Seattle Children's Hospital
name: The Children's Hospital at Montefiore
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2022-09-22
Enrollment: 2000
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants who meet eligibility criteria and consent to enrollment on the study.

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 .

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of participants developing a RVI within one-year post transplant.
timeFrame: Baseline through 1-year post-transplant
Secondary outcomes:
measure: Predicted risk of a post-transplant recipient developing an aRVI within one-year post-transplant
timeFrame: 1 year
measure: Predicted risk of a post-transplant recipient developing an aRVI from Day 100 to one year post transplant.
timeFrame: Day +100 through 1-year post-transplant
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham's (UAB)
state: Alabama
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
city: Washington
country: United States
facility: Children's National Medical
state: District of Columbia
city: Miami
country: United States
facility: University if Miami
state: Florida
city: Atlanta
country: United States
facility: Emory and Children's Healthcare of Atlanta
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medicine Comer Children's Hospital
state: Illinois
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: C.S. Mott Children's Hospital
state: Michigan
city: Detroit
country: United States
facility: Children's Hospital of Michigan
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Bronx
country: United States
facility: The Children's Hospital at Montefiore
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Pittsburgh
country: United States
facility: UPMC
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Memphis
country: United States
facility: Le Bonheur Children's Hospital
state: Tennessee
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
city: Memphis
country: United States
facility: UT Le Bonheur
state: Tennessee
city: Fort Worth
country: United States
facility: Cook Children's
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: MD Anderson Center Center
state: Texas
city: Houston
country: United States
facility: UTHealth Houston
state: Texas
city: Seattle
country: United States
facility: Seattle Childrens
state: Washington
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Gabriela Maron, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Arkansas Children's Hospital Research Institute
name: William J. Steinbach, MD
role: PRINCIPAL_INVESTIGATOR
References: