Efficacy of Letermovir in Preventing Cytomegalovirus (CMV) Infection in Lung Transplant Recipients vs. Valganciclovir.
Key facts
- Phase
- Phase 2
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- How often do I need to come in, and for how long each time?
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Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Maimónides Biomedical Research Institute of Córdoba
- Trial code
- NCT06057194EU 2023-504384-16-00
- Record updated
- 28 September 2023
- Original description
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."Read full original descriptionShow less
Prospective Study to Assess the Efficacy of Letermovir Prophylaxis in Preventing CMV Infection in Lung Transplant Recipients Compared to a Retrospective Cohort Treated With Standard Valganciclovir Prophylaxis for 12 Months (LETERCOR Study)
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."
Inclusion: 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; 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: Patients with multivisceral transplant; Receiving a different antiviral prophylaxis other than ganciclovir prior to letermovir prophylaxis; Patients with concurrent renal and hepatic insufficiency; Patients with multivisceral transplant; HIV-infected patients; HIV-infected patients; Patients unable to comply with the follow-up protocol.