NCT05708755PHASE2Recruiting
CMV Immunity Monitoring in Lung Transplant Recipients
NYU Langone Health
Start Date
9/13/2024
Completion Date
5/1/2028
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 Criteria
Age Range: 18 years to 99 years
Inclusion Criteria:
1. Received a lung transplant, or multi-organ transplant involving a lung at NYU Langone Health
2. Pre-existing serological immunity to CMV (R+)
3. Able and willing to provide informed consent
Exclusion Criteria:
1. Anti-thymocyte globulin induction immunosuppression
2. Perioperative desensitization
3. Pregnant or breastfeeding women
Interventions
DEVICE
Cytomegalovirus T Cell Immunity Panel (CMV-TCIP)
DIAGNOSTIC_TEST
Donor-Derived Cell-Free DNA (dd-cfDNA) Assay
DRUG
Valganciclovir
Conditions
Lung Transplant; Complications
Locations
NYU Langone Health
New York, New York 10016
United States