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NCT03924219 · ClinicalTrials.gov registry record
CMV T Cell Immunity in Pediatric Solid Organ Transplant Recipients
A clinical trial of CMV and Heart Transplant Infection, sponsored by Vanderbilt University Medical Center.
- Active
- Registry status
- 120
- Enrollment target
- 12
- Study locations
NCT03924219 is a study of CMV and Heart Transplant Infection that is active but no longer recruiting, run by Vanderbilt University Medical Center. The registered enrollment target is 120 participants, below the 345-participant average among 7 other CMV trials with a reported enrollment target (65% lower). The trial reports 12 study locations across 11 states.
The verdict
NCT03924219, a study of CMV and Heart Transplant Infection, is active but no longer recruiting, sponsored by Vanderbilt University Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- 120 participants
- Enrollment target
- 12
- Study locations
Study Summary
CMV infection and disease remain a significant clinical challenge for pediatric solid organ transplant (SOT) recipients. Current prevention strategies are limited to prophylaxis in which antiviral medication is administered for a period of several months or preemption in which close monitoring of CMV viral load from the peripheral blood is performed and treatment is initiated when CMV is detected. Each of these strategies has risks, costs, and limitations associated with it. Recently, assays for measurement of an individual patient's CMV immunity have been developed and are clinically available. One of these is the Viracor CMV T cell Immunity Panel. This flow cytometry based assay is performed on peripheral blood and measures cytokine release in response to CMV antigen stimulation by flow cytometry. The thresholds for this assay that confer protection against CMV infection in pediatric SOT recipients are not known. Defining CMV-specific cell mediated immune response thresholds that confer protection against CMV reactivation could inform patient specific durations of antiviral prophylaxis or pre-emptive surveillance testing. Therefore, the objective of this study is to quantify CMVresponsive T lymphocyte populations by flow cytometry (Viracor CMV T cell Immunity Panel) in pediatric heart, kidney, and liver transplant recipients within the first year of transplantation and to investigate potential threshold values that correlate with protection against CMV infection (DNAemia).
Conditions Studied
Interventions
- OTHER CMV T cell Immunity Assay
Study Locations (12)
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
- University of Pittsburgh Medical Center/Children's Hospital of Pittsburgh - Pittsburgh
California
- Stanford University Medical Center/Lucile Packard Children's Hospital Stanford - Stanford
Georgia
- Emory University Medical Center/Children's Hospital of Atlanta - Atlanta
Illinois
- Northwestern University Medical Center/Lurie Children's Hospital of Chicago - Chicago
Massachusetts
- Boston Children's Hospital - Boston
Missouri
- Children's Mercy Hospital - Kansas City
Nebraska
- University of Nebraska Medical Center - Omaha
New York
- Albert Einstein College of Medicine/Children's Hospital at Montefiore - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2019-06-03 |
| Est. Completion | 2025-07 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03924219
The ClinicalTrials.gov registry entry for NCT03924219 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 345-participant average among 7 other CMV trials with a reported enrollment target (65% lower). The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with CMV appearing as the primary indexed condition, and to 1 intervention - of which CMV T cell Immunity Assay is the first listed.
NCT03924219 reports 12 study locations spanning 11 distinct geographic areas - top geographies include Pennsylvania, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT03924219 about?
NCT03924219 is a clinical study titled "CMV T Cell Immunity in Pediatric Solid Organ Transplant Recipients". CMV infection and disease remain a significant clinical challenge for pediatric solid organ transplant (SOT) recipients. Current prevention strategies are limited to prophylaxis in which antiviral medication is administered for a period of several months or preemption in which close monitoring of CM...
What is the current status of trial NCT03924219?
This trial is currently active not recruiting. The enrollment target is 120 participants. The study started on 2019-06-03. Estimated completion is 2025-07.
What conditions does trial NCT03924219 study?
This clinical trial studies the following conditions: CMV, Heart Transplant Infection, Kidney Transplant Infection, Liver Transplant Infection.
What interventions are being tested in trial NCT03924219?
The interventions under investigation include: CMV T cell Immunity Assay (OTHER).
Who is sponsoring clinical trial NCT03924219?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03924219 being conducted?
This trial has 12 study locations across California, Georgia, Illinois, Massachusetts, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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