Study Results
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View full resultsBasic Information
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TERMINATED
NA
7 participants
INTERVENTIONAL
2009-10-31
2011-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo tablet
Placebo
Placebo
Placebo tablet identical to active therapy. 1 tablet per day
Rosuvastatin (crestor)
Experimental arm
Rosuvastatin (crestor)
20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge
Interventions
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Rosuvastatin (crestor)
20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge
Placebo
Placebo tablet identical to active therapy. 1 tablet per day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Requirement for ICU (or ICU step-down) admission due to respiratory distress defined as:
* SaO2/FiO2 \< 315 or PaO2/FiO2 \< 300
* Multiply by PB/760 (when altitude exceeds 51000 ft)
* For FiO2 for non-intubated patients see Appendix B
Participants must receive the first dose of study drug within 48 hours following ICU admission for confirmed or suspected influenza or be excluded from participation in the study.
Exclusion Criteria
2. Age less than 13 years
3. Weight less than 40 kg
4. Unable to receive or unlikely to absorb enteral study drug (e.g. patients with partial or complete mechanical bowel obstruction, intestinal ischemia, infarction, and short bowel syndrome)
5. Allergy or intolerance to statins\*
6. Pregnancy or breast feeding
7. Receiving niacin, fenofibrate, cyclosporine, gemfibrozil, or any antiviral protease inhibitor including but not limited to lopinavir and ritonavir.
8. Existing clinically significant myositis or myopathy or has a measured CK greater than 5,000 U/L
9. Requiring statin for underlying disease as determined by the patients attending physician team\*\*.
10. Severe chronic liver disease (Child-Pugh Score 11-15)
11. Previous myocardial infarction or thrombotic stroke within the past 6 months 11.12. Any significant funding in the patient's medical history or physical or psychiatric exam prior to randomization that, in the opinion of the investigator, would affect patient safety or compliance or ability to deliver the study drug according to protocol
13 Years
ALL
No
Sponsors
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Gordon Bernard
OTHER
Responsible Party
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Gordon Bernard
Professor of Medicine
Principal Investigators
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Gordon R Bernard, M.D.
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University
Locations
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University of Arkansas
Little Rock, Alaska, United States
Maricopa Integrated Health System
Phoenix, Arizona, United States
Stanford
Stanford, California, United States
Northwestern University
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
Johns Hopkins Hospital
Baltiomore, Maryland, United States
Boston University
Boston, Massachusetts, United States
Baystate Medical Center
Springfiled, Massachusetts, United States
Columbia University
New York, New York, United States
Mt Sinai
New York, New York, United States
Moses H. Cone Memorial Hospital
Greensboro, North Carolina, United States
Metro Health
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
University of Oregon
Portland, Oregon, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Erlanger
Chattanooga, Tennessee, United States
Vanderbilt University
Nashville, Tennessee, United States
University of Texas
San Antonio, Texas, United States
Intermountain
Murray, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Countries
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Other Identifiers
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STIP
Identifier Type: -
Identifier Source: org_study_id
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