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Ganciclovir to Prevent Reactivation of Cytomegalovirus in Patients With Acute Respiratory Failure and Sepsis | Clinical Trials | Clareo Health

TERMINATEDPHASE3

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

NCT04706507•Fred Hutchinson Cancer Center

View on ClinicalTrials.gov

Summary

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

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

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):
+12 more criteria

Locations (20)

University of Colorado Denver

Denver, Colorado, United States

Johns Hopkins University

Baltimore, Maryland, United States

Brigham & Women's Hospital

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

Washington University

St Louis, Missouri, United States

Montefioure Medical Center

The Bronx, New York, United States

Duke University

Durham, North Carolina, United States

Wakeforest University, School of Medicine

Winston-Salem, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

Key Dates

Start Date

June 29, 2021

Primary Completion Date

October 25, 2024

Completion Date

April 8, 2025

Last Updated

December 12, 2025

Enrollment

205

ACTUAL participants

Conditions

Acute Respiratory Failure

Interventions

IV Ganciclovir

DRUG

Normal saline

DRUG

Global Physiotherapy in ICU Patients With High Risk Extubation Failure

NCT05423301

Acute Respiratory Failure

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RECRUITING

Evaluating the Safety and Performance of the MiniLung Petite Kit in Neonatal and Pediatric Patients With Acute Respiratory and Cardiac Failure

NCT06750536

Extracorporeal Membrane Oxygenation ComplicationNeonatal Aspiration Pneumonia+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 12, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Global Physiotherapy in ICU Patients With High Risk Extubation Failure

Evaluating the Safety and Performance of the MiniLung Petite Kit in Neonatal and Pediatric Patients With Acute Respiratory and Cardiac Failure

Waveform Capnography Compared to Colorimetric Carbon Dioxide Detection During Tracheal Intubation of Critically Ill Adults

Closed Loop Oxygen Control in INtubated Critically Ill Patients

Practice of Oxygenation and Respiratory Support During Fiberoptic Bronchoscopy

China Extracorporeal Life Support Registry