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| Name | Class |
|---|---|
| Viracor Eurofins | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lung Transplant Recipients | Experimental | Lung transplant recipients with pre-transplant serological immunity to CMV. CMV-TCIP will be measured every 3 months post-transplant with antiviral prophylaxis discontinued when threshold is exceeded. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cytomegalovirus T Cell Immunity Panel (CMV-TCIP) | Device | Whole blood assay that evaluates T cell (CD4 and CD8) responses to cytomegalovirus (CMV) antigens via intracellular cytokine staining (ICS). |
| Measure | Description | Time Frame |
|---|---|---|
| CMV Viremia-Free Survival | Defined as the the time from lung transplant until the first detection of CMV DNA in patients' blood. | Up to Month 12 Post-Transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of CMV Viremia | Number of times CMV DNA is detected in patients' blood. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tyler Lewis | Contact | 866-838-5864 | Tyler.lewis@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Luis Angel, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
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| ID | Term |
|---|---|
| D000077562 | Valganciclovir |
| ID | Term |
|---|---|
| D015774 | Ganciclovir |
| D000212 | Acyclovir |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 |
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|
| Donor-Derived Cell-Free DNA (dd-cfDNA) Assay | Diagnostic Test | Determines the percentage of circulating cell-free DNA (cfDNA) in transplant recipients derived from donor grafts. |
|
|
| Valganciclovir | Drug | 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. |
|
| 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. | Up to Month 12 Post-Transplant |
| Incidence of Bacterial Pneumonia | Measure of non-CMV post-transplant infectious complications. | Up to Month 12 Post-Transplant |
| Incidence of Aspergillus Infection | Measure of non-CMV post-transplant infectious complications. | Up to Month 12 Post-Transplant |
| Incidence of Varicella Zoster Reactivation | Measure of non-CMV post-transplant infectious complications. | Up to Month 12 Post-Transplant |
| Incidence of Neutropenia | Up to Month 12 Post-Transplant |
| Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |