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

Completed · Phase 2 · Has a placebo group

Conditions studied: Acute Lung Injury, Acute Respiratory Distress Syndrome, Respiratory Failure

In brief

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.

Key facts

Study ID

NCT01335932

Run by

Fred Hutchinson Cancer Center

People needed

160

Starts

2011-03-10

Expected to finish

2016-10-28

Last updated by the study team

2018-08-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject/next of kin informed consent
• Age >= 18 years
• CMV IgG seropositive. The following tests are acceptable:
• FDA licensed test in a local lab approved by the coordinating center (FHCRC, Seattle, WA).
• Test in central study lab (ARUP, Salt Lake City, UT)
• A report that patient has previously been tested and found to be CMV seropositive at any time (a credible next of kin report is acceptable; confirmatory test will be done but results are not required for randomization)
• Intubated and requiring mechanical positive pressure ventilation (including Acute Lung Injury/ARDS (EA Consensus Definition))
• Meets criteria for either:
• Severe sepsis criteria (as defined in appendix G) within a 24-hour time period within the 120 hour window
• OR
• Trauma with respiratory failure and an ISS score > 15 within a 24 hour time period, and within the 120 hour window (where mechanical ventilation is not due solely to a head injury)
• On the day of randomization (by local criteria):
• Not eligible for SBT (use of sedation and/or vasopressor does not specifically contraindicate SBT),or
• Failed SBT

You may not qualify if…

• BMI > 60 (1st weight during hospital admission)
• 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:
• within 6 months: alemtuzumab, antithymocyte/antilymphocyte antibodies
• within 3 months: immunomodulator therapy (TNF-alpha antagonist, rituximab, tocilizumab, IL1 receptor antagonist and other biologics)
• within 30 days:
• corticosteroids > 10 mg/day (chronic administration, daily average over the time period)
• topical steroids are permissible
• use of hydrocortisone in "stress doses" up to 100 mg four times a day (400mg/daily) for up to 4 days prior to randomization is permissible
• use of temporary short-term (up to 2 weeks) increased doses of systemic steroids (up tp 1 mg/kg) for exacerbation of chronic conditions are permissible.
• methotrexate (> 10.0 mg/week)
• azathioprine (> 75 mg/day)
• Note: if no information on these agents is available in the history and no direct or indirect evidence exists from the history that any condition exists that requires treatment with these agents (based on the investigator's assessment), the subject may be enrolled. For all drug information, next-of-kin estimates are acceptable. See Appendix D for commonly prescribed immunosuppressive agents.
• Expected to survive < 72 hours (in the opinion of the investigator)
• Has been hospitalized for > 120 hours (subjects who are transferred from a chronic care ward, such as a rehabilitation unit, with an acute event are acceptable).
• Pregnant or breastfeeding (either currently or expected within one month).

Where it is running

• University of Colorado / National Jewish Health / Swedish Medical Center — Denver, Colorado, United States
• Northwestern University — Chicago, Illinois, United States
• Baystate Critical Care Medicine / Tufts University School of Medicine — Springfield, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Wakeforest University, School of Medicine — Winston-Salem, North Carolina, United States
• The Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Ohio State University Medical Center — Columbus, Ohio, United States
• The Oregon Clinic — Portland, Oregon, United States
• University of Pennsylvania Medical Center — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• University of Vermont College of Medicine — Burlington, Vermont, United States
• University of Virginia — Charlottesville, Virginia, United States
• Harborview Medical Center — Seattle, Washington, United States
• University of Washington Medical Center / Harborview Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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