Ganciclovir for Acute Respiratory Failure
(GRAIL^3 Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot have used anti-CMV drugs like ganciclovir within seven days before joining the trial.
Is ganciclovir generally safe for humans?
Ganciclovir has been used to treat various conditions, and while it can be effective, it may cause side effects like neutropenia (low white blood cell count), thrombocytopenia (low platelet count), and kidney issues. However, in some studies, no severe drug-related toxicities were observed, indicating it can be safe under certain conditions.12345
How is the drug Ganciclovir unique for treating acute respiratory failure?
Ganciclovir is unique for treating acute respiratory failure because it is an antiviral medication typically used for viral infections, which may be relevant if the respiratory failure is caused by a virus, especially in immunocompromised patients. This approach differs from standard treatments like noninvasive ventilation, which focus on supporting breathing rather than addressing viral causes.678910
What is the purpose of this trial?
This is a phase 3 study designed to evaluate whether the administration of ganciclovir increases ventilator-free days in immunocompetent patients with sepsis associated acute respiratory failure. Our hypothesis is that IV ganciclovir administered early in critical illness will effectively suppress CMV reactivation in CMV seropositive adults with sepsis-associated acute respiratory failure thereby leading to improved clinical outcomes
Research Team
Michael Boeckh, MD
Principal Investigator
Fred Hutchinson Cancer Center
Eligibility Criteria
This trial is for adults over 18 in ICU with sepsis-associated acute respiratory failure who are CMV seropositive and expected to need respiratory support for at least two more days. Excluded are those with organ transplants, certain immunodeficiencies, severe neutropenia, allergies to ganciclovir, recent chemotherapy, advanced liver disease, or on other investigational anti-CMV drugs.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive IV ganciclovir or placebo for 5 days, followed by once daily administration until hospital discharge
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Ganciclovir
Find a Clinic Near You
Who Is Running the Clinical Trial?
Fred Hutchinson Cancer Research Center
Lead Sponsor
Fred Hutchinson Cancer Center
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator