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 @ 3:32 AM
Ignite Modification Date:
2025-12-25 @ 3:32 AM
NCT ID:
NCT05576805
Eligibility Criteria:
Inclusion Criteria:
(Cohort 1) Resistant / Refractory or Intolerant:
1. Aged greater than or equal to (\>=) 18 years at the time of the SOT.
2. Received an SOT after January 1, 2016.
3. Diagnosed with asymptomatic or symptomatic CMV infection any time after the SOT date.
4. Required \>=1 anti-CMV agent to manage CMV infection and were subsequently considered:
1. resistant to currently available anti-CMV agent; OR
2. refractory to currently available anti-CMV agent; OR
3. intolerant to currently available anti-CMV agent.
5. Follow-up information is available for at least 12 months from the index date (that is, date when the participant was first considered resistant, refractory or intolerant to anti-CMV agent) or death, whichever occurs first.
6. Provided written informed consent prior to the initiation of any study procedures (unless waiver was granted by the Institutional Ethical Committee \[IEC\]).
(Cohort 2) Pre-emptive treatment for CMV viremia:
1. Aged \>=18 years at the time of the SOT.
2. Received an SOT after January 1, 2019.
3. Diagnosed with CMV viremia any time after the SOT date and received pre-emptive anti-CMV agent.
4. Follow-up information is available for at least 12 months from the index date (that is, date when the participant was first preemptively treated with an anti-CMV agent) or death, whichever occurs first.
5. Provided written informed consent prior to the initiation of any study procedures (unless waiver was granted by the IEC).
Exclusion Criteria: (Cohorts 1 and 2)
1. Diagnosed as being positive for human immunodeficiency virus before the SOT.
2. Unable to demonstrate a minimum of 12 months of follow-up from the index date (example, incomplete information on dates showing follow-up time).
3. Participation in a clinical trial related to CMV treatment during the study period .
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05576805
Study Brief:
Protocol Section:
NCT05576805