CMV Immunity Monitoring in Lung Transplant Recipients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cytomegalovirus T Cell Immunity Panel (CMV-TCIP), Donor-Derived Cell-Free DNA (dd-cfDNA) Assay, Valganciclovir.
- Who it may be relevant to
- Registry conditions: Lung Transplant; Complications. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Cytomegalovirus T Cell Immunity and Antiviral Prophylaxis Minimization in Lung Transplant Recipients
Overview
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.
Interventions
- Device Cytomegalovirus T Cell Immunity Panel (CMV-TCIP)
Whole blood assay that evaluates T cell (CD4 and CD8) responses to cytomegalovirus (CMV) antigens via intracellular cytokine staining (ICS). - Diagnostic test Donor-Derived Cell-Free DNA (dd-cfDNA) Assay
Determines the percentage of circulating cell-free DNA (cfDNA) in transplant recipients derived from donor grafts. - Drug Valganciclovir
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.
Primary outcome measures
- CMV Viremia-Free Survival [Time frame: Up to Month 12 Post-Transplant]
Secondary outcome measures (7)
- Incidence of CMV Viremia [Time frame: Up to Month 12 Post-Transplant]
- Incidence of CMV Viremia Requiring Treatment [Time frame: Up to Month 12 Post-Transplant]
- Incidence of Treatment-Resistant CMV Viremia [Time frame: Up to Month 12 Post-Transplant]
- Incidence of Bacterial Pneumonia [Time frame: Up to Month 12 Post-Transplant]
- Incidence of Aspergillus Infection [Time frame: Up to Month 12 Post-Transplant]
- Incidence of Varicella Zoster Reactivation [Time frame: Up to Month 12 Post-Transplant]
- Incidence of Neutropenia [Time frame: Up to Month 12 Post-Transplant]
Eligibility criteria
Inclusion criteria
- 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 criteria
- Anti-thymocyte globulin induction immunosuppression
- Perioperative desensitization
- Pregnant or breastfeeding women
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- NYU Langone Health — New York
Identifiers
NCT: NCT05708755 · 22-01138