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

Primary Purpose

Infections, Cytomegalovirus

Status
Not yet recruiting
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Letermovir 240 mg Oral Tablet
Sponsored by
Maimónides Biomedical Research Institute of Córdoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infections, Cytomegalovirus focused on measuring Lung transplant, CMV prophylaxis, Cytomegalovirus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Universitario Reina Sofia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Letermovir (prospective cohort)

Valganciclovir (retrospective cohort)

Arm Description

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

Retrospective cohort, of patients treated with Valganciclovir during 12 months

Outcomes

Primary Outcome Measures

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."

Secondary Outcome Measures

Antiviral prophylaxis received:
Doses administered of Letermovir or Valganciclovir
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)
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
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)
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
Reduction of the antiviral dose related to CMV antiviral toxicity
Number of events of reduction
Substitution of letermovir by intravenous ganciclovir or foscarnet IV, related to CMV antiviral toxicity
Number of substitutions
Dose changes of immunosuppressive therapy related to CMV antiviral toxicity
Number of changes
Changes of immunosuppressive therapy related to CMV antiviral toxicity
Number of changes
Use of granulocyte colony-stimulating factors (G-CSF).
Number of events (use)
Incidence of leucopenia
Incidence of leucopenia. (leucopenia will be considered if the total leukocyte count is less than 3,000/mL)
Incidence of neutropenia
Incidence of leucopenia. (neutropenia will be considered if the total neutrophil count is less than 1,000/mL)
Hospital readmission associated with CMV complication
Number of events
Incidence of viral, bacterial, or opportunistic fungal infections during the study follow-up period.
Number of events
Incidence of renal toxicity directly related to CMV antivirals.
Number of events

Full Information

First Posted
September 15, 2023
Last Updated
September 25, 2023
Sponsor
Maimónides Biomedical Research Institute of Córdoba
Collaborators
MERCK SHARP & DOHME DE ESPAÑA S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT06057194
Brief Title
Efficacy of Letermovir in Preventing Cytomegalovirus (CMV) Infection in Lung Transplant Recipients vs. Valganciclovir.
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
April 2027 (Anticipated)
Study Completion Date
April 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maimónides Biomedical Research Institute of Córdoba
Collaborators
MERCK SHARP & DOHME DE ESPAÑA S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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."

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Cytomegalovirus
Keywords
Lung transplant, CMV prophylaxis, Cytomegalovirus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Clinical trial of a prospective cohort compared to a retrospective (historical control) cohort.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Letermovir (prospective cohort)
Arm Type
Experimental
Arm Description
2 tablets of 240 milligrams (mg) Letermovir orally once daily. during 12 months
Arm Title
Valganciclovir (retrospective cohort)
Arm Type
No Intervention
Arm Description
Retrospective cohort, of patients treated with Valganciclovir during 12 months
Intervention Type
Drug
Intervention Name(s)
Letermovir 240 mg Oral Tablet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of CMV disease/replication
Description
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."
Time Frame
During 12 months after initiation of prophylaxis
Secondary Outcome Measure Information:
Title
Antiviral prophylaxis received:
Description
Doses administered of Letermovir or Valganciclovir
Time Frame
During 12 months after initiation of prophylaxis
Title
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)
Description
Drug Dose (mg/hour)
Time Frame
During 12 months after initiation of prophylaxis
Title
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)
Description
Drug Administration Route
Time Frame
During 12 months after initiation of prophylaxis
Title
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)
Description
Drug treatment duration (days)
Time Frame
During 12 months after initiation of prophylaxis
Title
Discontinuation of non-antiviral CMV Medications: Any non-antiviral therapy received as standard of care (SoC) for the management of CMV (e.g., immunoglobulins)
Description
Drug Reason for Discontinuation
Time Frame
During 12 months after initiation of prophylaxis
Title
Reduction of the antiviral dose related to CMV antiviral toxicity
Description
Number of events of reduction
Time Frame
During 12 months after initiation of prophylaxis
Title
Substitution of letermovir by intravenous ganciclovir or foscarnet IV, related to CMV antiviral toxicity
Description
Number of substitutions
Time Frame
During 12 months after initiation of prophylaxis
Title
Dose changes of immunosuppressive therapy related to CMV antiviral toxicity
Description
Number of changes
Time Frame
During 12 months after initiation of prophylaxis
Title
Changes of immunosuppressive therapy related to CMV antiviral toxicity
Description
Number of changes
Time Frame
During 12 months after initiation of prophylaxis
Title
Use of granulocyte colony-stimulating factors (G-CSF).
Description
Number of events (use)
Time Frame
During 12 months after initiation of prophylaxis
Title
Incidence of leucopenia
Description
Incidence of leucopenia. (leucopenia will be considered if the total leukocyte count is less than 3,000/mL)
Time Frame
During 12 months after initiation of prophylaxis
Title
Incidence of neutropenia
Description
Incidence of leucopenia. (neutropenia will be considered if the total neutrophil count is less than 1,000/mL)
Time Frame
During 12 months after initiation of prophylaxis
Title
Hospital readmission associated with CMV complication
Description
Number of events
Time Frame
During 12 months after initiation of prophylaxis
Title
Incidence of viral, bacterial, or opportunistic fungal infections during the study follow-up period.
Description
Number of events
Time Frame
During 12 months after initiation of prophylaxis
Title
Incidence of renal toxicity directly related to CMV antivirals.
Description
Number of events
Time Frame
During 12 months after initiation of prophylaxis

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jose C Garrido Gracia, Ph.D
Phone
+34677906567
Email
josecarlos.garrido@imibic.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julián C De la Torre Cisneros, MD
Organizational Affiliation
Hospital Universitario Reina Sofia de Cordoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Reina Sofia
City
Cordoba
State/Province
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aurora Paez Vega, Ph.D
Email
aumapave@hotmail.com
First Name & Middle Initial & Last Name & Degree
Julián C De la Torre Cisneros, MD

12. IPD Sharing Statement

Learn more about this trial

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

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