Understanding respiratory viral infections in pediatric transplant recipients
Multi-Center Molecular Diagnosis and Host Response of Respiratory Viral Infections in Pediatric Transplant Recipients
This study is trying to see if measuring respiratory viruses before a transplant can help predict which kids might get respiratory infections afterward.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Arkansas Children's Hospital Research Institute Academic / other |
| Locations | 27 sites (Birmingham, Alabama and 26 other locations) |
| Trial ID | NCT05550298 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the relationship between pre-transplant respiratory viral load and the occurrence of respiratory viral infections (RVI) in pediatric patients who have undergone hematopoietic cell or solid organ transplants. Participants will provide nasal swabs and blood samples at enrollment and if they develop an RVI within one year post-transplant. The study also seeks to develop predictive classifiers based on immunological profiles collected before and after the transplant to identify those at risk for acute respiratory viral infections. The goal is to improve patient outcomes by enhancing pre-transplant screening processes.
Who should consider this trial
Good fit: Ideal candidates are children under 18 years scheduled to receive a hematopoietic cell transplant or solid organ transplant.
Not a fit: Patients who are not undergoing a transplant or are over 18 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better predictive tools for preventing respiratory viral infections in vulnerable pediatric transplant recipients.
How similar studies have performed: While this approach is novel in the context of pediatric transplant recipients, similar studies in adult populations have shown promise in predicting viral infections post-transplant.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Birmingham, Alabama and 26 other locations
- 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 (Recruiting)
- Emory and Children's Healthcare of Atlanta — Atlanta, Georgia, United States (Recruiting)
- University of Chicago Medicine Comer Children's Hospital — Chicago, Illinois, United States (Recruiting)
- University of Louisville — Louisville, Kentucky, United States (Recruiting)
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
- C.S. Mott Children's Hospital — Ann Arbor, Michigan, United States (Recruiting)
- Children's Hospital of Michigan — Detroit, Michigan, United States (Recruiting)
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
- Washington University — St Louis, Missouri, United States (Recruiting)
- University of Nebraska Medical Center — Omaha, Nebraska, United States (Recruiting)
- The Children's Hospital at Montefiore — The Bronx, New York, United States (Recruiting)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)
- Nationwide Children's Hospital — Columbus, Ohio, United States (Recruiting)
- Upmc — Pittsburgh, Pennsylvania, United States (Recruiting)
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
- Le Bonheur Children's Hospital — Memphis, Tennessee, United States (Recruiting)
- St. Jude Children's Research Hospital — Memphis, Tennessee, United States (Recruiting)
- UT Le Bonheur — Memphis, Tennessee, United States (Recruiting)
- Cook Children's — Fort Worth, Texas, United States (Recruiting)
- Baylor College of Medicine — Houston, Texas, United States (Recruiting)
- MD Anderson Center Center — Houston, Texas, United States (Recruiting)
- UTHealth Houston — Houston, Texas, United States (Recruiting)
- Seattle Childrens — Seattle, Washington, United States (Recruiting)
- Children's Hospital of Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Gabriela Maron, MD — St. Jude Children's Research Hospital
- Study coordinator: Gabriela Maron, MD
- Email: referralinfo@stjude.org
- Phone: 866-278-5833
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.