Prospective study to evaluate the efficacy of letermovir prophylaxis for the prevention of CMV infection in lung transplant recipients compared to a retrospective cohort treated with standard valganciclovir prophylaxis for 12 months (LETERCOR Study).
- Conditions
- lung transplant patients (D+/R-)Therapeutic area: Diseases [C] - Virus Diseases [C02]
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 70
18 years and older, Lung transplant patients (D+/R-) pre-transplant, Have an undetectable PCR-CMV within 96 hours prior to the start of letermovir prophylaxis (prospective cohort), Patients who have given their written informed consent (prospective cohort), Patients treated with valganciclovir prophylaxis for 12 months (retrospective cohort), Patients transplanted in the 2 years prior to the start of the study (retrospective cohort), Patients with a complete follow-up of 13 months and with comparable data with respect to the prospective cohort that allow the evaluation of the main variables of the study (retrospective cohort)
HIV-infected patients, Multivisceral transplant patients, Patients who cannot comply with the study protocol (prospective cohort), Receiving an antiviral prophylaxis other than ganciclovir prior to letermovir prophylaxis (prospective cohort), Patients with simultaneous renal and hepatic insufficiency (prospective cohort)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the efficacy of 12-month letermovir prophylaxis in lung transplant recipients (D+/R-) compared with a historical cohort of lung transplant recipients (D+/R-) who received 12 months of valganciclovir prophylaxis to prevent CMV disease;Secondary Objective: Evaluation of changes in medication directly related to CMV antiviral toxicity during the 12 months after the start of treatment:;Primary end point(s): Incidence of CMV disease/replication for 12 months after initiation of prophylaxis.
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Administered doses of Letermovir or Valganciclovir;Secondary end point(s):CMV Medications: Any non-antiviral therapy received as SoC for CMV management (eg immunoglobulins);Secondary end point(s):Changes in the patient's medication directly related to the toxicity of CMV antivirals;Secondary end point(s):Incidence of leukopenia. (Leukopenia will be considered if the total leukocyte number is less than 3,000/mL and neutropenia if the total neutrophil number is less than 1,000/mL);Secondary end point(s):Hospital readmission associated with CMV complications;Secondary end point(s):Incidence of opportunistic viral, bacterial, or fungal infections during the study follow-up period;Secondary end point(s):Incidence of renal toxicity directly related to CMV antivirals