Lung Transplant; Complications
Conditions
Brief 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.
Interventions
DEVICECytomegalovirus 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_TESTDonor-Derived Cell-Free DNA (dd-cfDNA) Assay
Determines the percentage of circulating cell-free DNA (cfDNA) in transplant recipients derived from donor grafts.
DRUGValganciclovir
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.
Sponsors
NYU Langone Health
Viracor Eurofins
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CMV Viremia-Free Survival | Up to Month 12 Post-Transplant | Defined as the the time from lung transplant until the first detection of CMV DNA in patients' blood. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of CMV Viremia | Up to Month 12 Post-Transplant | Number of times CMV DNA is detected in patients' blood. |
| Incidence of CMV Viremia Requiring Treatment | Up to Month 12 Post-Transplant | Number of times treatment is necessary after CMV DNA is detected in patients' blood. |
| Incidence of Treatment-Resistant CMV Viremia | Up to Month 12 Post-Transplant | Number of times treatment for CMV Viremia does not appear effective after CMV DNA is detected in patients' blood. |
| Incidence of Bacterial Pneumonia | Up to Month 12 Post-Transplant | Measure of non-CMV post-transplant infectious complications. |
| Incidence of Aspergillus Infection | Up to Month 12 Post-Transplant | Measure of non-CMV post-transplant infectious complications. |
| Incidence of Varicella Zoster Reactivation | Up to Month 12 Post-Transplant | Measure of non-CMV post-transplant infectious complications. |
| Incidence of Neutropenia | Up to Month 12 Post-Transplant | — |
Countries
United States
Contacts
CONTACTTyler Lewis
PRINCIPAL_INVESTIGATORLuis Angel, MD
NYU Langone Health
Outcome results
None listed