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NCT05550298 · ClinicalTrials.gov registry record
Multi-Center Molecular Diagnosis and Host Response of Respiratory Viral Infections in Pediatric Transplant Recipients
A clinical trial of Hematopoietic Cell Transplant and Solid Organ Transplant, sponsored by Arkansas Children's Hospital Research Institute.
- Recruiting
- Registry status
- 2,000
- Enrollment target
- 20
- Study locations
NCT05550298: Recruiting study of Hematopoietic Cell Transplant and Solid Organ Transplant, sponsored by Arkansas Children's Hospital Research Institute.
NCT05550298 is a study of Hematopoietic Cell Transplant and Solid Organ Transplant that is actively recruiting participants, run by Arkansas Children's Hospital Research Institute. The registered enrollment target is 2,000 participants, above the 56-participant average among 6 other Hematopoietic Cell Transplant trials with a reported enrollment target (3471% higher). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05550298, a study of Hematopoietic Cell Transplant and Solid Organ Transplant, is actively recruiting participants, sponsored by Arkansas Children's Hospital Research Institute.
- RECRUITING
- Registry status
- 2,000 participants
- Enrollment target
- 20
- Study locations
Study 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 .
Primary Outcome
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.
Conditions Studied
Study Locations (20)
Michigan
- C.S. Mott Children's Hospital - Ann Arbor
- Children's Hospital of Michigan - Detroit
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
- Nationwide Children's Hospital - Columbus
Tennessee
- Le Bonheur Children's Hospital - Memphis
- St. Jude Children's Research Hospital - Memphis
Alabama
- University of Alabama at Birmingham's (UAB) - Birmingham
Arkansas
- Arkansas Children's Hospital - Little Rock
District of Columbia
- Children's National Medical - Washington D.C.
Florida
- University if Miami - Miami
Georgia
- Emory and Children's Healthcare of Atlanta - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,000 participants |
| Start Date | 2022-12-13 |
| Est. Completion | 2029-08 |
What NCT05550298 shows while recruiting
NCT05550298 is an observational study that tracks outcomes without assigning an intervention. Its 2,000 participants enrollment target places it among the larger protocols in the corpus, above the 56-participant average among 6 other Hematopoietic Cell Transplant trials with a reported enrollment target (3471% higher).
The record links to 3 conditions, with Hematopoietic Cell Transplant appearing as the primary indexed condition, and to 0 interventions.
NCT05550298 names 20 study sites across 17 states, led by Michigan, Ohio, Tennessee.
Frequently Asked Questions
What is clinical trial NCT05550298 about?
NCT05550298 is a clinical study titled "Multi-Center Molecular Diagnosis and Host Response of Respiratory Viral Infections in Pediatric Transplant Recipients". 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 scre...
What is the current status of trial NCT05550298?
This trial is currently recruiting. The enrollment target is 2,000 participants. The study started on 2022-12-13. Estimated completion is 2029-08.
What conditions does trial NCT05550298 study?
This clinical trial studies the following conditions: Hematopoietic Cell Transplant, Solid Organ Transplant, Respiratory Viral Infection.
Who is sponsoring clinical trial NCT05550298?
This trial is sponsored by Arkansas Children's Hospital Research Institute, which has 97 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05550298 being conducted?
This trial has 20 study locations across Alabama, Arkansas, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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