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:
2025-12-24 @ 1:09 PM
Ignite Modification Date:
2025-12-24 @ 1:09 PM
NCT ID:
NCT03339661
Eligibility Criteria:
Inclusion Criteria:
* Male or female over 18 years old without weight or ethnicity criteria, kidney transplant.
* Patient affiliated or beneficiary of a social security scheme.
* Patient with symptomatic or non-symptomatic CMV infection requiring curative treatment with ganciclovir or valganciclovir.
* Free, informed and written consent signed by the participant and the investigator (at the latest, on the day of inclusion and before any examination required by the research).
Exclusion Criteria:
* Resistance documented to antivirals.
* Hemodialysis patient.
* Number of polymorphonuclear neutrophils less than 500 / μL and / or number of platelets less than 25,000 / μL, and / or lower hemoglobin 8 g / dL.
* Contraindication to valganciclovir, including known hypersensitivity to valganciclovir and / or aciclovir and / or valaciclovir or ganciclovir or their excipients, known severe intolerance to valganciclovir or ganciclovir.
* Women of childbearing age without a negative pregnancy test at baseline and without effective contraception (estrogen-progestin, intrauterine device) throughout the study period and two months after cessation of the follow-up period.
* Nursing women.
* Men without mechanical contraception during treatment and for at least 90 days after treatment.
* Ongoing participation in another clinical trial evaluating a drug. Participation in an observational study will not be considered a contraindication.
* The patient's foreseeable inability to comply with planned visits in the protocol.
* Non-negativation of CMV PCR at 8 weeks
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03339661
Study Brief:
Protocol Section:
NCT03339661