STIP: Statin Trial for Influenza Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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Hypothesis: Rosuvastatin therapy will improve mortality and reduce the need for mechanical ventilation in patients experiencing respiratory distress as a complication of influenza.

Official Title
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Randomized, Placebo Controlled Trial of the Effectiveness of Statins for Preventing Mortality Following ICU Admission for Influenza Complications

Conditions
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Acute Respiratory Distress Syndrome, Influenza, H1N1 Influenza

Intervention / Treatment
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* Drug: Rosuvastatin (crestor)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo tablet<br>Placebo | Drug: Placebo<br>* Placebo tablet identical to active therapy. 1 tablet per day<br>* Other names: Placebo, sugar pill;|
| Experimental: Rosuvastatin (crestor)<br>Experimental arm | Drug: Rosuvastatin (crestor)<br>* 20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge<br>* Other names: Crestor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ARDS, H1N1, Influenza, Statin