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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMaimónides Biomedical Research Institute of Córdoba

About this trial

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."

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Letermovir 240 mg Oral Tablet

Treatment groups

90 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Maimónides Biomedical Research Institute of Córdoba

Lead sponsor

MERCK SHARP & DOHME DE ESPAÑA S.A.

Collaborator