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

Phase 2Not Yet RecruitingNCT06057194

Maimónides Biomedical Research Institute of Córdoba90 enrolled

Overview

The goal of this quasi-experimental multicenter before-after cohort study, phase II study is to evaluate the efficacy of 12-month letermovir prophylaxis in lung transplant recipients (D+/R-) compared to a historical cohort of lung transplant recipients (D+/R-) who received 12 months of valganciclovir prophylaxis to prevent CMV disease."

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Infections, Cytomegalovirus

Interventions

Letermovir 240 mg Oral TabletDRUG

Treatment will commence as soon as subjects can receive oral medication, with a maximum timeframe of 28 days after transplantation. If patients cannot receive oral medication after transplantation, initial prophylaxis with ganciclovir per clinical practice will be allowed. Medication will be discontinued 12 months after treatment initiation.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital Universitario Reina Sofia

Córdoba, Córdoba, Spain

Outcomes

Primary Outcomes

Incidence of CMV disease/replication

CMV replication: The term 'replication' can be used to indicate evidence of multiplication and is sometimes used interchangeably with CMV infection CMV disease: It is defined as symptomatic replication or invasive disease of organs or tissues that requires treatment at the investigator's discretion."