500 Participants Needed

Ganciclovir for Acute Respiratory Failure

(GRAIL^3 Trial)

Recruiting at 19 trial locations
MB
LK
Overseen ByLouise Kimball, PhD,RN
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Fred Hutchinson Cancer Research Center
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human 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

MB

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

I have an infection causing severe breathing problems.
I have tested positive for CMV antibodies.
I will need help with breathing for at least 2 more days.
See 4 more

Exclusion Criteria

Pregnant or breastfeeding (either currently or expected within one month)
I was born with an immune deficiency and need medicine to prevent infections.
I haven't taken anti-CMV drugs in the last 7 days.
See 14 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive IV ganciclovir or placebo for 5 days, followed by once daily administration until hospital discharge

Up to hospital discharge

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Ganciclovir
Trial Overview The study tests if IV Ganciclovir can increase ventilator-free days in patients with sepsis-induced acute respiratory failure by preventing CMV reactivation. It's a phase 3 trial hypothesizing that early treatment leads to better outcomes.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: IV GanciclovirExperimental Treatment1 Intervention
5mg/kg IV twice daily for 5 days, then followed by IV ganciclovir once daily until hospital discharge
Group II: PlaceboPlacebo Group1 Intervention
normal saline IV twice daily for 5 days, then followed by IV normal saline once daily until hospital discharge

Find a Clinic Near You

Who Is Running the Clinical Trial?

Fred Hutchinson Cancer Research Center

Lead Sponsor

Trials
444
Recruited
148,000+

Fred Hutchinson Cancer Center

Lead Sponsor

Trials
583
Recruited
1,341,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

References

Evaluation of ganciclovir for cytomegalovirus disease. [2019]
Risk factors for ganciclovir-induced thrombocytopenia and leukopenia. [2015]
Safety and efficacy of prolonged cytomegalovirus prophylaxis with intravenous ganciclovir in pediatric and young adult lung transplant recipients. [2018]
Ganciclovir treatment of serious cytomegalovirus infection in heart and heart-lung transplant recipients. [2021]
Treatment of cytomegalovirus retinitis with ganciclovir. [2019]
Non-invasive ventilation in immunosuppressed patients with pneumonia and extrapulmonary sepsis. [2019]
Prognosis of critically ill immunocompromised patients with virus-detected acute respiratory failure. [2023]
Noninvasive ventilation for patients presenting with acute respiratory failure: the randomized controlled trials. [2020]
Early non-invasive ventilation for acute respiratory failure in immunocompromised patients (IVNIctus): study protocol for a multicenter randomized controlled trial. [2022]
Use of noninvasive ventilation in immunocompromised patients with acute respiratory failure: a systematic review and meta-analysis. [2018]
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