Multi-Center Molecular Diagnosis and Host Response of Respiratory Viral Infections in Pediatric Transplant Recipients
Study Details
Study Description
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:
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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.
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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 .
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
The investigators will collect a nasal swab and blood sample from the participant when the participant is enrolled on the study, 100 days after the participant transplant and if the participant develop a RVI in the first year after transplant.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
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| 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. |
Outcome Measures
Primary Outcome Measures
- Proportion of participants developing a RVI within one-year post transplant. [Baseline through 1-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.
Secondary Outcome Measures
- Predicted risk of a post-transplant recipient developing an aRVI within one-year post-transplant [1 year]
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
- Predicted risk of a post-transplant recipient developing an aRVI from Day 100 to one year post transplant. [Day +100 through 1-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
Eligibility Criteria
Criteria
Recipient Inclusion Criteria
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Less than 18 years at the time of anticipated transplant
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Participant meets one of the following criteria:
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scheduled to receive allogeneic hematopoietic cell transplant within 14 days of enrollment or
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Scheduled to or received solid organ transplant within 7 days before or after enrollment
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Participant is receiving care at the time of enrollment at one of the study participating institutions.
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Parent/guardian willing and able to provide informed consent, and if appropriate, child willing and able to provide informed assent.
Donor Inclusion Criteria
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Donor for HCT recipient enrolled on the VIPER study.
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Willing and able to provide informed consent.
Exclusion Criteria:
Recipient Exclusion Criteria
None
Donor Exclusion Criteria
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Is not an HCT donor for a participant enrolled on the VIPER study.
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Not available to provide pre-transplant research blood sample.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Arkansas Children's Hospital | Little Rock | Arkansas | United States | 72202 |
| 2 | Boston Children's Hospital | Boston | Massachusetts | United States | 02115 |
| 3 | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | United States | 45229 |
| 4 | St. Jude Children's Research Hospital | Memphis | Tennessee | United States | 38105 |
| 5 | Cook Children's | Fort Worth | Texas | United States | 76104 |
Sponsors and Collaborators
- St. Jude Children's Research Hospital
- National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
- Principal Investigator: Gabriela Maron, MD, St. Jude Children's Research Hospital
- Principal Investigator: William J. Steinbach, MD, Arkansas Children's Hospital Research Institute
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- VIPER
- 7R01AI159684-02