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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 belowSelect...
I have an infection causing severe breathing problems.
Select...
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:Select...
I was born with an immune deficiency and need medicine to prevent infections.
Select...
I have a tracheostomy and use a ventilator 24/7.
Select...
I have had an organ transplant and am on immunosuppressants.
Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 28 days
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
147,471 Total Patients Enrolled
Fred Hutchinson Cancer CenterLead Sponsor
571 Previous Clinical Trials
1,340,447 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,935 Previous Clinical Trials
47,791,831 Total Patients Enrolled
10 Trials studying Acute Respiratory Failure
37,124 Patients Enrolled for Acute Respiratory Failure
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an infection causing severe breathing problems.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.I have a tracheostomy and use a ventilator 24/7.You are allergic to ganciclovir.I had a stem cell transplant less than 6 months ago if it was my own cells, or less than a year ago if it was from a donor.I have tested positive for CMV antibodies.I have had an organ transplant and am on immunosuppressants.I have not taken specific immune-weakening drugs recently.Your body does not have enough infection-fighting white blood cells.Currently in prison.I am in a trial for a drug that might affect CMV or cause blood issues.I have not had chemotherapy in the last 3 months.I will need help with breathing for at least 2 more days.My liver disease is classified as severe (Child Class C).I am currently being treated in an Intensive Care Unit.You have a weakened immune system, such as being HIV positive.I have been in the hospital for more than 5 days.I need home oxygen for my severe lung condition.I am older than 18 years.I am experiencing severe breathing problems.
Research Study Groups:
This trial has the following groups:- Group 1: IV Ganciclovir
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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