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NCT Number: NCT06057194

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

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."

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Key information

Conditions

Infections, Cytomegalovirus Cytomegalovirus Infections DNA Virus Infections Herpesviridae Infections Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

Location contact

Aurora Paez Vega, Ph.D

CONTACT

[email protected]

Julián C De la Torre Cisneros, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Letermovir 240 mg Oral Tablet

Drug

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 outcomes

  1. Incidence of CMV disease/replication

    Time frame: 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 outcomes

  1. Antiviral prophylaxis received:

    Time frame: During 12 months after initiation of prophylaxis

    Doses administered of Letermovir or Valganciclovir

  2. 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)

    Time frame: During 12 months after initiation of prophylaxis

    Drug Dose (mg/hour)

  3. 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)

    Time frame: During 12 months after initiation of prophylaxis

    Drug Administration Route

  4. 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)

    Time frame: During 12 months after initiation of prophylaxis

    Drug treatment duration (days)

  5. Discontinuation of non-antiviral CMV Medications: Any non-antiviral therapy received as standard of care (SoC) for the management of CMV (e.g., immunoglobulins)

    Time frame: During 12 months after initiation of prophylaxis

    Drug Reason for Discontinuation

  6. Reduction of the antiviral dose related to CMV antiviral toxicity

    Time frame: During 12 months after initiation of prophylaxis

    Number of events of reduction

  7. Substitution of letermovir by intravenous ganciclovir or foscarnet IV, related to CMV antiviral toxicity

    Time frame: During 12 months after initiation of prophylaxis

    Number of substitutions

  8. Dose changes of immunosuppressive therapy related to CMV antiviral toxicity

    Time frame: During 12 months after initiation of prophylaxis

    Number of changes

  9. Changes of immunosuppressive therapy related to CMV antiviral toxicity

    Time frame: During 12 months after initiation of prophylaxis

    Number of changes

  10. Use of granulocyte colony-stimulating factors (G-CSF).

    Time frame: During 12 months after initiation of prophylaxis

    Number of events (use)

  11. Incidence of leucopenia

    Time frame: 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)

  12. Incidence of neutropenia

    Time frame: 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)

  13. Hospital readmission associated with CMV complication

    Time frame: During 12 months after initiation of prophylaxis

    Number of events

  14. Incidence of viral, bacterial, or opportunistic fungal infections during the study follow-up period.

    Time frame: During 12 months after initiation of prophylaxis

    Number of events

  15. Incidence of renal toxicity directly related to CMV antivirals.

    Time frame: During 12 months after initiation of prophylaxis

    Number of events

Study contacts

Contact information is provided by the study sponsor or research team.

Jose C Garrido Gracia, Ph.D

CONTACT

[email protected]

+34677906567

Sponsors and collaborators

Lead sponsor

Maimónides Biomedical Research Institute of Córdoba

Other

Collaborators

  • MERCK SHARP & DOHME DE ESPAÑA S.A.

Registry information

Official study 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)

Acronym: LETERCOR

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Sep 28, 2023
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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