Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT06057194
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06057194
Study Brief:
Protocol Section:
NCT06057194