Breakthrough CMV DNAemia in CMV Seronegative Recipients of CMV Seropositive Lung Transplantation During Antiviral Prophylaxis With Valganciclovir A Pilot Study

What this Trial Is About

Researchers are investigating how often cytomegalovirus (CMV) infection breaks through antiviral prevention in lung transplant patients who have a CMV mismatch, meaning the donor had CMV before but the recipient did not. This infection is a common and serious risk after lung transplantation. The study focuses on patients receiving antiviral prophylaxis with valganciclovir and aims to understand the frequency of breakthrough infections, side effects from the antiviral treatment, and the development of resistance to the medication. The study follows about 40 lung transplant patients who receive standard care antiviral prophylaxis with valganciclovir for 6 to 12 months after transplantation. During the study, CMV DNA levels will be tested every two weeks up to 24 or 52 weeks post-transplant, then weekly from weeks 24 to 36 or 52 to 64. If CMV infection occurs despite prophylaxis, samples will be collected to check for antiviral resistance. Side effects like neutropenia and leukopenia will be monitored, along with any changes in medication or treatment. Participants will have their medical history reviewed at baseline and will undergo regular blood tests and CMV DNA monitoring as part of their standard care. Researchers will track side effects, antiviral resistance, and clinical outcomes such as infections, lung function, retransplantation, and survival for up to 64 weeks. This observational study aims to provide detailed data on CMV breakthrough rates and related complications in this high-risk group of lung transplant patients.

Breakthrough CMV Lung Transplant -Multicentre