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Trial Information

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

Official Title: A Randomized Double-Blind Placebo-Controlled Trial of Ganciclovir/Valganciclovir for Prevention of Cytomegalovirus Reactivation in Acute Injury of the Lung and Respiratory Failure (The GRAIL Study)

Summary

To evaluate whether administration of ganciclovir reduces serum IL-6 levels (i.e. reduction between baseline and 14 days post-randomization) in immunocompetent adults with severe sepsis or trauma associated respiratory failure. Primary Hypotheses: - In CMV seropositive adults with severe sepsis or trauma , pulmonary and systemic CMV reactivation amplifies and perpetuates both lung and systemic inflammation mediated through specific cytokines, and contributes to pulmonary injury and multiorgan system failure, AND - Prevention of CMV reactivation with ganciclovir decreases pulmonary and systemic inflammatory cytokines that are important in the pathogenesis of sepsis and trauma related complications.

Phase: Phase 2

Sponsor: Fred Hutchinson Cancer Research Center

Overall Contacts:

Michael Boeckh, MD
206-667-6706

Ajit Limaye, MD
Phone: 206-598-1041

Locations (11)

Country	State	City	Zip	Facility and Contact
United States	Colorado	Denver	80206	University of Colorado / National Jewish Health Stephen K Frankel, MD 303-398-1521 Stephen K Frankel, MD Principal Investigator
United States	Massachusetts	Springfield	01199	Baystate Critical Care Medicine / Tufts University School of Medicine Jay S Steingrub, MD 413-794-5439 Jay S Steingrub, MD Principal Investigator
United States	Michigan	Ann Arbor	48109-5360	University of Michigan Robert Hyzy, MD 734-936-5201 Robert Hyzy, MD Principal Investigator
United States	North Carolina	Winston-Salem	27157	Wakeforest University, School of Medicine Robert Hite, MD 336-716-8898 Robert Hite, MD Principal Investigator
United States	Ohio	Columbus	43210	Ohio State University Medical Center Matthew Exline, MD 614-293-4925 Matthew.Exline@osumc.edu Matthew Exline, MD Principal Investigator
United States	Oregon	Portland	97220	The Oregon Clinic David Hotchkin, MD 503-963-3030 dhotchkin@orclinic.com David Hotchkin, MD Principal Investigator
United States	Pennsylvania	Philadelphia	19104-6160	University of Pennsylvania Medical Center Mark Mikkelsen, MD 215-615-5416 Mark Mikkelsen, MD Principal Investigator
United States	Pennsylvania	Pittsburgh	15261	University of Pittsburgh Medical Center Scott Gunn, MD 412-958-8398 Scott Gunn, MD Principal Investigator
United States	Vermont	Burlington	05405	University of Vermont College of Medicine Polly Parsons, MD 802-847-6177 Renee Stapleton, MD Principal Investigator Polly Parsons, MD Principal Investigator
United States	Washington	Seattle	98195	University of Washington Medical Center Ajit Limaye, MD 206-598-1041 ALimaye@medicine.washington.edu Robert Rakita, MD Sub-Investigator Michael Boeckh, MD Sub-Investigator Paul Pottinger, MD Sub-Investigator
United States	Washington	Seattle	98104	Harborview Medical Center Joseph Cuschieri, MD 206-744-6448 jcuschie@u.washington.edu

NCT ID:NCT01335932

Date Last Changed: April 26, 2013