The purpose of this study is to determine the safety and feasibility of using a laboratory test to guide duration of antiviral prophylaxis with valganciclovir (medication used to prevent viral infections) after lung transplant. The laboratory test, inSIGHT™ CMV T Cell Immunity Panel, measures patients' immune response to a common viral infection known as cytomegalovirus (CMV). The goal of this study will be to safely decrease how long patients need to take valganciclovir based on the results of the CMV T Cell Immunity Panel.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
50
Whole blood assay that evaluates T cell (CD4 and CD8) responses to cytomegalovirus (CMV) antigens via intracellular cytokine staining (ICS).
Determines the percentage of circulating cell-free DNA (cfDNA) in transplant recipients derived from donor grafts.
Delivered as standard of care for post-lung transplant immunosuppression and infection prophylaxis. Started on the first day post-transplant at a standard dose of 900 mg daily and continued for 12 months. Dose adjustments may be necessary based on renal function and/or adverse effects (e.g. neutropenia). Dose adjustments are standard based on package insert recommendations.
NYU Langone Health
New York, New York, United States
RECRUITINGCMV Viremia-Free Survival
Defined as the the time from lung transplant until the first detection of CMV DNA in patients' blood.
Time frame: Up to Month 12 Post-Transplant
Incidence of CMV Viremia
Number of times CMV DNA is detected in patients' blood.
Time frame: Up to Month 12 Post-Transplant
Incidence of CMV Viremia Requiring Treatment
Number of times treatment is necessary after CMV DNA is detected in patients' blood.
Time frame: Up to Month 12 Post-Transplant
Incidence of Treatment-Resistant CMV Viremia
Number of times treatment for CMV Viremia does not appear effective after CMV DNA is detected in patients' blood.
Time frame: Up to Month 12 Post-Transplant
Incidence of Bacterial Pneumonia
Measure of non-CMV post-transplant infectious complications.
Time frame: Up to Month 12 Post-Transplant
Incidence of Aspergillus Infection
Measure of non-CMV post-transplant infectious complications.
Time frame: Up to Month 12 Post-Transplant
Incidence of Varicella Zoster Reactivation
Measure of non-CMV post-transplant infectious complications.
Time frame: Up to Month 12 Post-Transplant
Incidence of Neutropenia
Time frame: Up to Month 12 Post-Transplant
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