STIP: Statin Trial for Influenza Patients

Stopped early · Not applicable · Has a placebo group

Conditions studied: Acute Respiratory Distress Syndrome, Influenza, H1N1 Influenza

In brief

To assess the efficacy and safety of oral rosuvastatin in patients with suspected or confirmed influenza who require intensive care unit (ICU) admission due to respiratory distress.

Key facts

Study ID

NCT00970606

Run by

Gordon Bernard

People needed

7

Starts

2009-10-01

Expected to finish

2011-07-01

Last updated by the study team

2017-03-22

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with suspected or confirmed influenza (Appendix A)
• 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.

You may not qualify if…

• No consent/inability to obtain consent
• Age less than 13 years
• Weight less than 40 kg
• 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)
• Allergy or intolerance to statins*
• Pregnancy or breast feeding
• Receiving niacin, fenofibrate, cyclosporine, gemfibrozil, or any antiviral protease inhibitor including but not limited to lopinavir and ritonavir.
• Existing clinically significant myositis or myopathy or has a measured CK greater than 5,000 U/L
• Requiring statin for underlying disease as determined by the patients attending physician team**.
• Severe chronic liver disease (Child-Pugh Score 11-15)
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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