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

Respiratory Viral Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05550298
• Other study ID #: VIPER
• Secondary ID: 7R01AI159684-02N
• Status: Recruiting
• Start date: December 13, 2022
• Est. completion date: August 2029

Study information

• Verified date: May 2024
• Source: St. Jude Children's Research Hospital
• Contact: Gabriela Maron, MD
• Phone: 866-278-5833
• Email: referralinfo[@]stjude.org
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

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 .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: August 2029
• Est. primary completion date: August 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Hematopoietic Cell Transplant
• Infections
• Respiratory Viral Infection
• Solid Organ Transplant
• Virus Diseases

Locations

Country	Name	City	State
United States	C.S. Mott Children's Hospital	Ann Arbor	Michigan
United States	Emory and Children's Healthcare of Atlanta	Atlanta	Georgia
United States	University of Alabama at Birmingham's (UAB)	Birmingham	Alabama
United States	Boston Children's Hospital	Boston	Massachusetts
United States	The Children's Hospital at Montefiore	Bronx	New York
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Chicago Medicine Comer Children's Hospital	Chicago	Illinois
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	Children's Hospital of Michigan	Detroit	Michigan
United States	Cook Children's	Fort Worth	Texas
United States	Baylor College of Medicine	Houston	Texas
United States	MD Anderson Center Center	Houston	Texas
United States	UTHealth Houston	Houston	Texas
United States	Arkansas Children's Hospital	Little Rock	Arkansas
United States	Le Bonheur Children's Hospital	Memphis	Tennessee
United States	St. Jude Children's Research Hospital	Memphis	Tennessee
United States	UT Le Bonheur	Memphis	Tennessee
United States	Children's Hospital of Wisconsin	Milwaukee	Wisconsin
United States	University of Minnesota	Minneapolis	Minnesota
United States	UPMC	Pittsburgh	Pennsylvania
United States	Washington University	Saint Louis	Missouri
United States	Seattle Childrens	Seattle	Washington
United States	Children's National Medical	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline through 1-year post-transplant
Secondary	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	1 year
Secondary	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	Day +100 through 1-year post-transplant

External Links

•   Clinical Trials Open at St. Jude
•   St. Jude Children's Research Hospital