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CMV preemptive therapy in high-risk immunocompetent major heart surgery patients. A multicenter, double blind, randomized, clinical trial (GAN-CAR).
EU CTIS ID: 2022-501429-19-00
What this study is testing
To determine the clinical impact of administering targeted pre-emptive antiviral therapy to high-risk (≥3 days in the cardiac surgery ICU and CMV viral load), immunocompetent adults, after MHS.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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 (TNFα 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.
See the full eligibility criteria
- 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 (TNFα 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.