CMV Immunity Monitoring in Lung Transplant Recipients
ConditionLung Transplant; Complications
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-99
SponsorNYU Langone Health
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Anti-thymocyte globulin induction immunosuppression
Perioperative desensitization
Pregnant or breastfeeding women
Trial design
Design model
Single group
Treatments tested in this trial
Cytomegalovirus T Cell Immunity Panel (CMV-TCIP)
DeviceWhole blood assay that evaluates T cell (CD4 and CD8) responses to cytomegalovirus (CMV) antigens via intracellular cytokine staining (ICS).
Donor-Derived Cell-Free DNA (dd-cfDNA) Assay
Diagnostic testDetermines the percentage of circulating cell-free DNA (cfDNA) in transplant recipients derived from donor grafts.
Valganciclovir
DrugDelivered 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Lung Transplant RecipientsExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
CMV Viremia-Free Survival
Defined as the the time from lung transplant until the first detection of CMV DNA in patients' blood.
Time frame
Up to Month 12 Post-TransplantSecondary outcomes
1
Incidence of CMV Viremia
Number of times CMV DNA is detected in patients' blood.
Time frame
Up to Month 12 Post-Transplant2
Incidence of CMV Viremia Requiring Treatment
Number of times treatment is necessary after CMV DNA is detected in patients' blood.
Time frame
Up to Month 12 Post-Transplant3
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.
Time frame
Up to Month 12 Post-Transplant4
Incidence of Bacterial Pneumonia
Measure of non-CMV post-transplant infectious complications.
Time frame
Up to Month 12 Post-TransplantSponsors and contacts
Click on the lead sponsor to view all of their trials.
NYU Langone Health
Lead sponsor
Viracor Eurofins
Collaborator
Source ClinicalTrials.gov