Clinical trial NCT06057194: Efficacy of Letermovir in Preventing Cytomegalovirus (CMV) Infection in Lung Transplant Recipients vs. Valganciclovir.
Official title: 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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Infections, Cytomegalovirus
Keywords: Lung transplant
CMV prophylaxis
Cytomegalovirus
Lead sponsor: Maimónides Biomedical Research Institute of Córdoba
Sponsor class: OTHER
Collaborators: name: MERCK SHARP & DOHME DE ESPAÑA S.A.
First posted: 2023-09-28
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clinical trial of a prospective cohort compared to a retrospective (historical control) cohort.
Primary purpose: TREATMENT

Brief 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."


Eligibility 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.

Primary outcomes:
measure: Incidence of CMV disease/replication
timeFrame: During 12 months after initiation of prophylaxis
Secondary outcomes:
measure: Antiviral prophylaxis received:
timeFrame: During 12 months after initiation of prophylaxis
measure: Dose of non anti-viral CMV Medications: Any non-antiviral therapy received as standard of care (SoC) for the management of CMV (e.g., immunoglobulins)
timeFrame: During 12 months after initiation of prophylaxis
measure: Administration route of non-antiviral CMV Medications: Any non-antiviral therapy received as standard of care (SoC) for the management of CMV (e.g., immunoglobulins)
timeFrame: During 12 months after initiation of prophylaxis
measure: Duration of treatment of non-antiviral CMV Medications: Any non-antiviral therapy received as standard of care (SoC) for the management of CMV (e.g., immunoglobulins)
timeFrame: During 12 months after initiation of prophylaxis
measure: Discontinuation of non-antiviral CMV Medications: Any non-antiviral therapy received as standard of care (SoC) for the management of CMV (e.g., immunoglobulins)
timeFrame: During 12 months after initiation of prophylaxis
measure: Reduction of the antiviral dose related to CMV antiviral toxicity
timeFrame: During 12 months after initiation of prophylaxis
measure: Substitution of letermovir by intravenous ganciclovir or foscarnet IV, related to CMV antiviral toxicity
timeFrame: During 12 months after initiation of prophylaxis
measure: Dose changes of immunosuppressive therapy related to CMV antiviral toxicity
timeFrame: During 12 months after initiation of prophylaxis
measure: Changes of immunosuppressive therapy related to CMV antiviral toxicity
timeFrame: During 12 months after initiation of prophylaxis
measure: Use of granulocyte colony-stimulating factors (G-CSF).
timeFrame: During 12 months after initiation of prophylaxis
measure: Incidence of leucopenia
timeFrame: During 12 months after initiation of prophylaxis
measure: Incidence of neutropenia
timeFrame: During 12 months after initiation of prophylaxis
measure: Hospital readmission associated with CMV complication
timeFrame: During 12 months after initiation of prophylaxis
measure: Incidence of viral, bacterial, or opportunistic fungal infections during the study follow-up period.
timeFrame: During 12 months after initiation of prophylaxis
measure: Incidence of renal toxicity directly related to CMV antivirals.
timeFrame: During 12 months after initiation of prophylaxis
Other outcomes:
Locations:
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
state: Córdoba
Study officials:
affiliation: Hospital Universitario Reina Sofia de Cordoba
name: Julián C De la Torre Cisneros, MD
role: PRINCIPAL_INVESTIGATOR
References: