STIP: Statin Trial for Influenza Patients (STIP)
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ClinicalTrials.gov Identifier: NCT00970606 |
Recruitment Status :
Terminated
(Inability to recruit participants since H1N1 epidemic resolved.)
First Posted : September 2, 2009
Results First Posted : April 24, 2013
Last Update Posted : March 22, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Respiratory Distress Syndrome Influenza H1N1 Influenza | Drug: Rosuvastatin (crestor) Drug: Placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 7 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Randomized, Placebo Controlled Trial of the Effectiveness of Statins for Preventing Mortality Following ICU Admission for Influenza Complications |
Study Start Date : | October 2009 |
Actual Primary Completion Date : | July 2011 |
Actual Study Completion Date : | July 2011 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo tablet
Placebo
|
Drug: Placebo
Placebo tablet identical to active therapy. 1 tablet per day
Other Name: Placebo, sugar pill |
Experimental: Rosuvastatin (crestor)
Experimental arm
|
Drug: Rosuvastatin (crestor)
20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge
Other Name: Crestor |
- Hospital Mortality to Day 28 or if Mortality is Not Different Between Groups, Time to Achieve Resolution of Respiratory Failure (e.g., Time to Unassisted Breathing in Survivors (Including Patient's Never Requiring Mechanical Ventilation). [ Time Frame: 28 days ]No outcome analyses were run as the sample size was not of sufficient size for a comparison with only 7 of >2000 participants planned/anticipated actually enrolled.

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Ages Eligible for Study: | 13 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00970606

Principal Investigator: | Gordon R Bernard, M.D. | Vanderbilt University |
Responsible Party: | Gordon Bernard, Professor of Medicine, Vanderbilt University Medical Center |
ClinicalTrials.gov Identifier: | NCT00970606 |
Other Study ID Numbers: |
STIP |
First Posted: | September 2, 2009 Key Record Dates |
Results First Posted: | April 24, 2013 |
Last Update Posted: | March 22, 2017 |
Last Verified: | June 2013 |
ARDS H1N1 Influenza Statin |
Influenza, Human Respiratory Distress Syndrome Respiratory Distress Syndrome, Newborn Acute Lung Injury Respiratory Tract Infections Infections Orthomyxoviridae Infections RNA Virus Infections Virus Diseases Respiratory Tract Diseases Lung Diseases Respiration Disorders |
Infant, Premature, Diseases Infant, Newborn, Diseases Lung Injury Rosuvastatin Calcium Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |