CMV Immunity Monitoring in Lung Transplant Recipients
Cytomegalovirus T Cell Immunity and Antiviral Prophylaxis Minimization in Lung Transplant Recipients
NYU Langone Health
50 participants
Sep 13, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria3
- Received a lung transplant, or multi-organ transplant involving a lung at NYU Langone Health
- Pre-existing serological immunity to CMV (R+)
- Able and willing to provide informed consent
Exclusion Criteria3
- Anti-thymocyte globulin induction immunosuppression
- Perioperative desensitization
- Pregnant or breastfeeding women
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05708755