STIP: Statin Trial for Influenza Patients
This study has been terminated.
(Inability to recruit participants since H1N1 epidemic resolved.)
Information provided by (Responsible Party):
Gordon Bernard, Vanderbilt University
First received: August 31, 2009
Last updated: June 28, 2013
Last verified: June 2013
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.
Acute Respiratory Distress Syndrome
Drug: Rosuvastatin (crestor)
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||Randomized, Placebo Controlled Trial of the Effectiveness of Statins for Preventing Mortality Following ICU Admission for Influenza Complications
Primary Outcome Measures:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||July 2011 (Final data collection date for primary outcome measure)
Placebo Comparator: Placebo tablet
Placebo tablet identical to active therapy. 1 tablet per day
Other Name: Placebo, sugar pill
Experimental: Rosuvastatin (crestor)
Drug: Rosuvastatin (crestor)
20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge
Other Name: Crestor
Hypothesis: Rosuvastatin therapy will improve mortality and reduce the need for mechanical ventilation in patients experiencing respiratory distress as a complication of influenza.
|Ages Eligible for Study:
||13 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00970606
||Gordon R Bernard, M.D.
No publications provided
||Gordon Bernard, Vice Chancellor of Research, Vanderbilt University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 31, 2009
|Results First Received:
||March 12, 2013
||June 28, 2013
||United States: Food and Drug Administration
Keywords provided by Vanderbilt University:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 16, 2014
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
RNA Virus Infections
Respiratory Tract Infections
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents