Efficacy of Letermovir in Preventing Cytomegalovirus (CMV) Infection in Lung Transplant Recipients vs. Valganciclovir.

Launched by MAIMÓNIDES BIOMEDICAL RESEARCH INSTITUTE OF CÓRDOBA · Sep 25, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating how effective a medication called letermovir is in preventing cytomegalovirus (CMV) infections in lung transplant recipients compared to another medication called valganciclovir. CMV is a virus that can cause serious health issues, especially in people who have had transplants. The study will involve adults over 18 years old who had lung transplants and are in a specific group (D+/R-). To be eligible, participants must have had a recent test showing no detectable CMV before starting letermovir and must provide written consent to join the study.

During the trial, participants receiving letermovir will be monitored for 12 months to see if it helps reduce the risk of CMV infection compared to those who previously received valganciclovir. It's important to note that certain individuals, such as those with HIV or other specific health conditions, will not be eligible to participate. This study aims to provide valuable information that could improve care for lung transplant recipients in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria (prospective cohort):
• • Adults over 18 years old
• • Lung transplant recipients (D+/R-) pre-transplant.
• • Having an undetectable CMV polymerase chain reaction assay (PCR) within the 96 hours prior to the start of letermovir prophylaxis.
• • Patients who have provided written informed consent.
• Exclusion Criteria (prospective cohort):
• • HIV-infected patients.
• • Patients with multivisceral transplant.
• • Patients unable to comply with the follow-up protocol.
• • Receiving a different antiviral prophylaxis other than ganciclovir prior to letermovir prophylaxis.
• • Patients with concurrent renal and hepatic insufficiency.
• Inclusion Criteria (retrospective cohort):
• • Adults over 18 years old. Lung transplant recipients (D+/R-) pre-transplant.
• • Patients treated with Valganciclovir prophylaxis for 12 months.
• • Patients transplanted within 2 years prior to the start of the study.
• • Patients with a complete 13-month follow-up and comparable data to the prospective cohort to evaluate the study's primary variables.
• Exclusion Criteria (retrospective cohort):
• • HIV-infected patients.
• • Patients with multivisceral transplant.