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

Phase 2

Not yet recruiting

• Conditions: Infections, Cytomegalovirus
• Interventions: Drug: Letermovir 240 mg Oral Tablet

• Registration Number: NCT06057194
• Lead Sponsor: Maimónides Biomedical Research Institute of Córdoba

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."

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-15
• Study First Submitted QC: 2023-09-25
• Last Update Submitted: 2023-09-25
• Study First Posted: 2023-09-28
• Last Update Posted: 2023-09-28
• Study Start: 2023-10
• Primary Completion: 2027-04
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Letermovir (prospective cohort)	Letermovir 240 mg Oral Tablet	2 tablets of 240 milligrams (mg) Letermovir orally once daily. during 12 months

Primary Outcome Measures

Name	Time	Method
Incidence of CMV disease/replication	During 12 months after initiation of prophylaxis	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

Name	Time	Method
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)	During 12 months after initiation of prophylaxis	Drug treatment duration (days)
Substitution of letermovir by intravenous ganciclovir or foscarnet IV, related to CMV antiviral toxicity	During 12 months after initiation of prophylaxis	Number of substitutions
Incidence of leucopenia	During 12 months after initiation of prophylaxis	Incidence of leucopenia. (leucopenia will be considered if the total leukocyte count is less than 3,000/mL)
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)	During 12 months after initiation of prophylaxis	Drug Dose (mg/hour)
Incidence of neutropenia	During 12 months after initiation of prophylaxis	Incidence of leucopenia. (neutropenia will be considered if the total neutrophil count is less than 1,000/mL)
Antiviral prophylaxis received:	During 12 months after initiation of prophylaxis	Doses administered of Letermovir or Valganciclovir
Discontinuation of non-antiviral CMV Medications: Any non-antiviral therapy received as standard of care (SoC) for the management of CMV (e.g., immunoglobulins)	During 12 months after initiation of prophylaxis	Drug Reason for Discontinuation
Reduction of the antiviral dose related to CMV antiviral toxicity	During 12 months after initiation of prophylaxis	Number of events of reduction
Use of granulocyte colony-stimulating factors (G-CSF).	During 12 months after initiation of prophylaxis	Number of events (use)
Hospital readmission associated with CMV complication	During 12 months after initiation of prophylaxis	Number of events
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)	During 12 months after initiation of prophylaxis	Drug Administration Route
Dose changes of immunosuppressive therapy related to CMV antiviral toxicity	During 12 months after initiation of prophylaxis	Number of changes
Incidence of viral, bacterial, or opportunistic fungal infections during the study follow-up period.	During 12 months after initiation of prophylaxis	Number of events
Changes of immunosuppressive therapy related to CMV antiviral toxicity	During 12 months after initiation of prophylaxis	Number of changes
Incidence of renal toxicity directly related to CMV antivirals.	During 12 months after initiation of prophylaxis	Number of events

Trial Locations

Locations (1)

Hospital Universitario Reina Sofia; 🇪🇸 Cordoba, Córdoba, Spain