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Can an antiviral drug help sepsis patients breathe on their own sooner?

NCT ID NCT04706507

Disease control Sponsor: Fred Hutchinson Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tested whether the antiviral drug ganciclovir could prevent reactivation of cytomegalovirus (CMV) in adults with sepsis who needed a breathing machine. The study enrolled 205 CMV-positive patients in the ICU with acute respiratory failure. Participants received either ganciclovir or a placebo for up to 28 days. The goal was to see if the drug increased the number of days they were free from breathing support. The trial was terminated early, so the full results are not available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ganciclovir (an antiviral drug)
What this could lead to
If it works, this could reduce the time patients with sepsis need a breathing machine, potentially improving recovery.
What could go wrong
The trial was terminated early, so results are limited. Ganciclovir can cause side effects like kidney problems or low blood cell counts.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

205 people

The number who actually took part.

Started

Jun 2021

Finished

Apr 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subject/next of kin informed consent * Age \> 18 years * CMV IgG seropositive by lateral flow assay (LFA) or standard serologic methods * Receiving care in an ICU * Acute respiratory failure as defined in Section 4.1.1. * Expected to require respiratory support for at least 2 more days after randomization * 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). Exclusion Criteria: * Known or suspected immunosuppression, including: * HIV+ (i.e. prior positive test or clinical signs of suspicion of HIV/AIDS; a negative HIV test is not required for enrollment) * stem cell transplantation: * within 6 months after autologous transplantation or * within 1 years after allogeneic transplantation (regardless of immunosuppression) * greater than 1 year of allogeneic transplantation if still taking systemic immunosuppression or prophylactic antibiotics (e.g. for chronic graft versus host disease) Note: if details of stem cell transplantation are unknown, patients who do not take systemic immunosuppression and do not take anti-infective prophylaxis are acceptable for enrollment and randomization. * solid organ transplantation with receipt of systemic immunosuppression (any time) * cytotoxic anti-cancer chemotherapy within the past three months (Note: next-of-kin estimate is acceptable) * congenital immunodeficiency requiring antimicrobial prophylaxis (e.g. TMP-SMX, dapsone, antifungal drugs, intravenous immunoglobulin) * receipt of one or more of the following in the indicated time period (see Appendix C): * within 6 months: alemtuzumab, antithymocyte/antilymphocyte antibodies, or other immunosuppressive drugs associated with CMV reactivation Note: if no information on these agents is available in the history and no direct or indirect evidence exists from the history that any condition exists that requires treatment with these agents (based on the investigator's assessment), the subject may be enrolled. For all drug information, next-of-kin estimates are acceptable. See Appendix C for commonly prescribed immunosuppressive agents. Information on the use of biologics with moderate immunosuppressive effect but no known effect on CMV are permitted and will be recorded in the CRFs. * Expected to survive \< 72 hours (in the opinion of the investigator) * Has been hospitalized for \> 120 hours (subjects who are transferred from a chronic care ward, such as a rehabilitation unit, with an acute event are acceptable). * Pregnant or breastfeeding (either currently or expected within one month). Note: for women of childbearing age (18-60 years, unless documentation of surgical sterilization \[hysterectomy, tubal ligation, oophorectomy\]), if a pregnancy test has not been done as part of initial ICU admission work-up, it will be ordered stat and documented to be negative before randomization. Both urine and blood tests are acceptable. * Absolute neutrophil count \< 1,000/mm3 (if no ANC value is available, the WBC must be \> 2500/mm3) * Use of anti-CMV drugs (cidofovir, letermovir, foscarnet, valganciclovir, ganciclovir) within seven (7) days of patient randomization. * Currently enrolled in an interventional trial of an investigational therapeutic agent known or suspected to have anti-CMV activity or to be associated with significant known hematologic toxicity (prior approval required). * At baseline patients who have both a tracheostomy, and have been on continuous 24-hour chronic mechanical ventilation. * Patients with Child Class C Cirrhosis. * Patients with severe (requiring home oxygen) pre-existing interstitial lung disease. * Allergy to ganciclovir * Incarcerated

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Conditions

The condition(s) this trial relates to.

acute respiratory failure infectious disease with sepsis cytomegalovirus infection prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute respiratory failure

Contacts and locations

Locations

  • Brigham & Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Duke University

    Durham, North Carolina, 27708, United States

  • Harborview Medical Center

    Seattle, Washington, 98104, United States

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Intermountain Medical Center

    Murray, Utah, 84107, United States

  • Johns Hopkins University

    Baltimore, Maryland, 21218, United States

  • Medical College of South Carolina

    Charleston, South Carolina, 29425, United States

  • Montefioure Medical Center

    The Bronx, New York, 10467, United States

  • Ohio State University Medical Center

    Columbus, Ohio, 43210, United States

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • University of Cincinnati

    Cincinnati, Ohio, 45221, United States

  • University of Colorado Denver

    Denver, Colorado, 80204, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109-5360, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15261, United States

  • University of Vermont College of Medicine

    Burlington, Vermont, 05405, United States

  • University of Washington Medical Center

    Seattle, Washington, 98195, United States

  • University of Wisconsin School of Medicine & Public Health

    Madison, Wisconsin, 53792, United States

  • Vanderbilt University

    Nashville, Tennessee, 37235, United States

  • Wakeforest University, School of Medicine

    Winston-Salem, North Carolina, 27157, United States

  • Washington University

    St Louis, Missouri, 63130, United States

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