CMV preemptive therapy in high-risk immunocompetent major heart surgery patients. A multicenter, double blind, randomized, clinical trial (GAN-CAR). - FIBHGM-ECNC002-2021

Fundacion Para La Investigacion Biomedica Del Hospital Gregorio Maranon0 个研究点目标入组 226 人开始时间: 2022年9月15日最近更新: 2024年7月22日

试验速览

暂无简介。

•Written informed consent must be obtained before any study-specific assessment is performed., Adult patients (=18 years old)., Patients that underwent a MHS in the last 90 days prior to inclusion., Patients remaining in the ICU at least 72h after the surgery., Female patients of child-bearing potential must have a negative urine pregnancy test at screening and agree to use reliable methods of contraception upon enrolment according to the recommendations provided by CTFG, during the treatment period and for one month following the last dose of investigational drug., Male patients must use a reliable method of contraception (if sexually active with a female of child-bearing potential) upon enrolment according to the recommendations provided by CTFG, during the treatment period, and for 3 months following the last dose of investigational drug., Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

•Immunocompromised patients: HIV positive infection, Neutropenia (neutrophile count <1000/mm3), Platelet count <25,000 U/µL, Hematopoietic transplant, Solid organ transplant needing immunosuppression, Chemotherapy received in the last 3 months prior to inclusion, Hereditary immunosuppression, Immunomodulatory drugs treatment (TNFa or rituximab) in the prior 3 months or alemtuzumab in the previous 6 months, Oral or intravenous (IV) corticosteroids treatment (>10 mg/day) in the last 30 days, Methotrexate treatment (=10 mg/s) or azathioprine treatment (=75 mg/s)., Females who are pregnant or breastfeeding., Patients treated with antiviral drugs that are active towards CMV, such as, ganciclovir, valganciclovir, acyclovir, valacyclovir, famciclovir, cidofovir, letermovir, maribavir, brincidofovir) in the last week before inclusion., Patients participating in another clinical trial with an experimental drug., Patients whose life expectancy is 48-72h., Patients with known hypersensitivity to valganciclovir, ganciclovir or any of the excipients.

发起方

Fundacion Para La Investigacion Biomedica Del Hospital Gregorio Maranon