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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at day 28 and day 180

Awards & highlights

GRAIL^3 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.Check my eligibility

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.See study design

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.

GRAIL^3 Trial 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.

GRAIL^3 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at day 28 and day 180

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at day 28 and day 180

This trial's timeline: 3 weeks for screening, Varies for treatment, and at day 28 and day 180 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Septicemia

Secondary outcome measures

To assess the number and severity of adverse events and serious adverse events in the first 28 days in both groups.

Ganciclovir

To evaluate whether ICU-free days in the first 28 days are different among ganciclovir recipients relative to placebo recipients.

+6 more

GRAIL^3 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

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Fred Hutchinson Cancer Research CenterLead Sponsor

443 Previous Clinical Trials

147,745 Total Patients Enrolled

Fred Hutchinson Cancer CenterLead Sponsor

556 Previous Clinical Trials

1,342,768 Total Patients Enrolled

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,836 Previous Clinical Trials

47,850,398 Total Patients Enrolled

9 Trials studying Acute Respiratory Failure

36,488 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other precedents for this type of virus treatment?

"IV Ganciclovir was first studied in 2019 at Hospital Universitario Vall D'Hebron. So far, there have been a total of 25 completed clinical trials. Right now, there are 3 active trials, a significant number of which are based in Nashville, Tennessee."

Answered by AI

Are people over the age of twenty able to enroll in this program?

"The age limit for this trial is 18-85, as specified in the eligibility criteria."

Answered by AI

Could I qualify to be a test subject in this experiment?

"This trial is looking for 500 individuals of all ages that have respiratory distress syndrome. The most crucial requirement is that applicants are expected to need respiratory support for at least 2 more days. Other requirements include: being CMV IgG seropositive, being treated in an ICU, and having an infection that is confirmed or suspected by a clinician."

Answered by AI

Is this research still recruiting participants?

"The clinicaltrials.gov website has information indicating that this trial is currently looking for patients. This study was posted on 29 June 2021 and updated on 9 July 2022. There are 20 locations enrolling 500 patients in total."

Answered by AI

Ganciclovir is known to have some serious side effects, but how does it compare to other treatments?

"There is both anecdotal and clinical evidence supporting the safety of IV Ganciclovir, which our team has given a score of 3."

Answered by AI

What are some of the primary benefits of IV Ganciclovir?

"IV Ganciclovir can be used to medicate patients with transplanted, cytomegalovirus, or cytomegalovirus infections."

Answered by AI

Could you ballpark the number of people enrolling in this clinical trial?

"That is correct. The online information available indicates that this study is still recruiting patients. The posting date was June 29th, 2021 and the most recent edit was on July 9th, 2022. They are looking for a total of 500 patients from 20 different locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ganciclovir to Prevent Reactivation of Cytomegalovirus in Patients With Acute Respiratory Failure and Sepsis

Michael Boeckh 2021. "Ganciclovir to Prevent Reactivation of Cytomegalovirus in Patients With Acute Respiratory Failure and Sepsis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04706507.

All > Cmv > Sepsis