Ganciclovir/Valganciclovir for Prevention of CMV Reactivation in Acute Injury of the Lung and Respiratory Failure

PHASE2CompletedINTERVENTIONAL
Enrollment

160

Participants

Timeline

Start Date

March 10, 2011

Primary Completion Date

June 17, 2016

Study Completion Date

October 28, 2016

Conditions
Acute Lung InjuryAcute Respiratory Distress SyndromeRespiratory Failure
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

Placebo

"For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.~The placebo is an IV solution that does not contain any active medications."

Trial Locations (14)

15261

University of Pittsburgh Medical Center, Pittsburgh

27157

Wakeforest University, School of Medicine, Winston-Salem

43210

Ohio State University Medical Center, Columbus

44195

The Cleveland Clinic Foundation, Cleveland

60611

Northwestern University, Chicago

80206

University of Colorado / National Jewish Health / Swedish Medical Center, Denver

97220

The Oregon Clinic, Portland

98104

Harborview Medical Center, Seattle

98195

University of Washington Medical Center / Harborview Medical Center, Seattle

01199

Baystate Critical Care Medicine / Tufts University School of Medicine, Springfield

48109-5360

University of Michigan, Ann Arbor

19104-6160

University of Pennsylvania Medical Center, Philadelphia

05405

University of Vermont College of Medicine, Burlington

22908-0546

University of Virginia, Charlottesville

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

collaborator

Genentech, Inc.

INDUSTRY

lead

Fred Hutchinson Cancer Center

OTHER