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

Maimónides Biomedical Research Institute of Córdoba

Status and phase: Not yet enrolling; Phase 2

Conditions: Infections, Cytomegalovirus

Treatments: Drug: Letermovir 240 mg Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT06057194

FCO-LET-2022-01

2023-504384-16-00 (Other Identifier)

Details and patient eligibility

About

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."

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Letermovir (prospective cohort)

Experimental group

Description:

2 tablets of 240 milligrams (mg) Letermovir orally once daily. during 12 months

Treatment:

Drug: Letermovir 240 mg Oral Tablet

Valganciclovir (retrospective cohort)

No Intervention group

Description:

Retrospective cohort, of patients treated with Valganciclovir during 12 months