Ganciclovir for Acute Respiratory Failure
(GRAIL^3 Trial)

Recruiting in Palo Alto (17 mi)

+19 other locations

Overseen byMichael Boeckh, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Fred Hutchinson Cancer Research Center

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

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

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.

+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.

+14 more

Participant Groups

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.

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