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

• Status: Not yet recruiting
• Trial end date: 2027-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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."

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maimónides Biomedical Research Institute of Córdoba
• Collaborator: MERCK SHARP & DOHME DE ESPAÑA S.A.
• Treatments: Letermovir

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.