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

Infections, Cytomegalovirus Clinical Trial

— LETERCOR  

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06057194
• Other study ID #: FCO-LET-2022-01
• Secondary ID: 2023-504384-16-0
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: October 2023
• Est. completion date: April 2027

Study information

• Verified date: September 2023
• Source: Maimónides Biomedical Research Institute of Córdoba
• Contact: Jose C Garrido Gracia, Ph.D
• Phone: +34677906567
• Email: josecarlos.garrido[@]imibic.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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."

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: April 2027
• Est. primary completion date: April 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Cytomegalovirus Infections
• Infections
• Infections, Cytomegalovirus

Intervention

Drug:
• Letermovir 240 mg Oral Tablet
Treatment will commence as soon as subjects can receive oral medication, with a maximum timeframe of 28 days after transplantation. If patients cannot receive oral medication after transplantation, initial prophylaxis with ganciclovir per clinical practice will be allowed. Medication will be discontinued 12 months after treatment initiation.

Locations

Country	Name	City	State
Spain	Hospital Universitario Reina Sofia	Cordoba	Córdoba

Sponsors (2)

Lead Sponsor	Collaborator
Maimónides Biomedical Research Institute of Córdoba	MERCK SHARP & DOHME DE ESPAÑA S.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of CMV disease/replication	CMV replication: The term 'replication' can be used to indicate evidence of multiplication and is sometimes used interchangeably with CMV infection; CMV disease: It is defined as symptomatic replication or invasive disease of organs or tissues that requires treatment at the investigator's discretion."	During 12 months after initiation of prophylaxis
Secondary	Antiviral prophylaxis received:	Doses administered of Letermovir or Valganciclovir	During 12 months after initiation of prophylaxis
Secondary	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)	Drug Dose (mg/hour)	During 12 months after initiation of prophylaxis
Secondary	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)	Drug Administration Route	During 12 months after initiation of prophylaxis
Secondary	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)	Drug treatment duration (days)	During 12 months after initiation of prophylaxis
Secondary	Discontinuation of non-antiviral CMV Medications: Any non-antiviral therapy received as standard of care (SoC) for the management of CMV (e.g., immunoglobulins)	Drug Reason for Discontinuation	During 12 months after initiation of prophylaxis
Secondary	Reduction of the antiviral dose related to CMV antiviral toxicity	Number of events of reduction	During 12 months after initiation of prophylaxis
Secondary	Substitution of letermovir by intravenous ganciclovir or foscarnet IV, related to CMV antiviral toxicity	Number of substitutions	During 12 months after initiation of prophylaxis
Secondary	Dose changes of immunosuppressive therapy related to CMV antiviral toxicity	Number of changes	During 12 months after initiation of prophylaxis
Secondary	Changes of immunosuppressive therapy related to CMV antiviral toxicity	Number of changes	During 12 months after initiation of prophylaxis
Secondary	Use of granulocyte colony-stimulating factors (G-CSF).	Number of events (use)	During 12 months after initiation of prophylaxis
Secondary	Incidence of leucopenia	Incidence of leucopenia. (leucopenia will be considered if the total leukocyte count is less than 3,000/mL)	During 12 months after initiation of prophylaxis
Secondary	Incidence of neutropenia	Incidence of leucopenia. (neutropenia will be considered if the total neutrophil count is less than 1,000/mL)	During 12 months after initiation of prophylaxis
Secondary	Hospital readmission associated with CMV complication	Number of events	During 12 months after initiation of prophylaxis
Secondary	Incidence of viral, bacterial, or opportunistic fungal infections during the study follow-up period.	Number of events	During 12 months after initiation of prophylaxis
Secondary	Incidence of renal toxicity directly related to CMV antivirals.	Number of events	During 12 months after initiation of prophylaxis