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Virus Therapy

Ganciclovir for Acute Respiratory Failure (GRAIL^3 Trial)

Phase 3
Recruiting
Led By Michael Boeckh, MD
Research Sponsored by Fred Hutchinson Cancer Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Infection confirmed or suspected by the treating clinician and felt to be the source of acute respiratory failure (Respiratory failure associated with infection confers at least 2 SOFA points above assumed baseline SOFA score of 0, thereby meeting Sepsis-3 definition)
CMV IgG seropositive by lateral flow assay (LFA) or standard serologic methods
Must not have
Congenital immunodeficiency requiring antimicrobial prophylaxis
At baseline patients who have both a tracheostomy, and have been on continuous 24-hour chronic mechanical ventilation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 28 days
Awards & highlights
Pivotal Trial

Summary

This trial will evaluate whether ganciclovir can help improve clinical outcomes for sepsis-associated acute respiratory failure in adults.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Ganciclovir may cause side effects like blood disorders (e.g., anemia), fever, rash, digestive issues (nausea or diarrhea), headache, insomnia and potential infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have an infection causing severe breathing problems.
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I have tested positive for CMV antibodies.
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I will need help with breathing for at least 2 more days.
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I am currently being treated in an Intensive Care Unit.
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I am older than 18 years.
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I am experiencing severe breathing problems.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I was born with an immune deficiency and need medicine to prevent infections.
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I have a tracheostomy and use a ventilator 24/7.
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I have had an organ transplant and am on immunosuppressants.
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I have not had chemotherapy in the last 3 months.
Select...
My liver disease is classified as severe (Child Class C).
Select...
I have been in the hospital for more than 5 days.
Select...
I need home oxygen for my severe lung condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 28 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Septicemia

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IV Ganciclovir
2011
Completed Phase 2
~160

Find a Location

Who is running the clinical trial?

Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
147,456 Total Patients Enrolled
Fred Hutchinson Cancer CenterLead Sponsor
570 Previous Clinical Trials
1,339,743 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,931 Previous Clinical Trials
47,766,208 Total Patients Enrolled
10 Trials studying Acute Respiratory Failure
37,124 Patients Enrolled for Acute Respiratory Failure

Media Library

Ganciclovir (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04706507 — Phase 3
Acute Respiratory Failure Research Study Groups: IV Ganciclovir, Placebo
Acute Respiratory Failure Clinical Trial 2023: Ganciclovir Highlights & Side Effects. Trial Name: NCT04706507 — Phase 3
Ganciclovir (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04706507 — Phase 3
~153 spots leftby May 2026
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