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TERMINATED
NCT04706507
PHASE3

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

Sponsor: 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

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

205

Start Date

2021-06-29

Completion Date

2025-04-08

Last Updated

2026-10-20

Healthy Volunteers

No

Interventions

DRUG

IV Ganciclovir

For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

DRUG

Normal saline

For first 5 days, dosing of intravenous saline is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV saline 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

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

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Ohio State University Medical Center

Columbus, Ohio, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Medical College of South Carolina

Charleston, South Carolina, United States

Vanderbilt University

Nashville, Tennessee, United States

Intermountain Medical Center

Murray, Utah, United States

University of Vermont College of Medicine

Burlington, Vermont, United States

Harborview Medical Center

Seattle, Washington, United States

University of Washington Medical Center

Seattle, Washington, United States

University of Wisconsin School of Medicine & Public Health

Madison, Wisconsin, United States