Status:
NOT_YET_RECRUITING
Efficacy of Letermovir in Preventing Cytomegalovirus (CMV) Infection in Lung Transplant Recipients vs. Valganciclovir.
Lead Sponsor:
Maimónides Biomedical Research Institute of Córdoba
Collaborating Sponsors:
MERCK SHARP & DOHME DE ESPAÑA S.A.
Conditions:
Infections, Cytomegalovirus
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06057194
Start Date
October 1 2023
End Date
April 1 2027
Last Update
September 28 2023
Active Locations (1)
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1
Hospital Universitario Reina Sofia
Córdoba, Córdoba, Spain, 14004