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)

Project: Research project

Project Details

Description

Primary Objectivev : 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.

Study Design Multicenter randomized placebo-controlled double-blind trial, [randomized in blocks for balance across study sites and genders, with interim analyses of safety].

Study Duration 6 months per patient
StatusFinished
Effective start/end date9/1/138/31/16

Funding

  • Fred Hutchinson Cancer Research Center (0000788107//5U01HL102547-03)
  • National Heart, Lung, and Blood Institute (0000788107//5U01HL102547-03)

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