STIP: Statin Trial for Influenza Patients

Not Applicable

Terminated

• Conditions: Acute Respiratory Distress Syndrome; Influenza; H1N1 Influenza
• Interventions: Drug: Placebo; Drug: Rosuvastatin (crestor)

• Registration Number: NCT00970606
• Lead Sponsor: Gordon Bernard

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2009-08-31
• Study First Submitted QC: 2009-09-01
• Study First Posted: 2009-09-02
• Study Start: 2009-10
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Results First Submitted: 2013-03-12
• Results First Submitted QC: 2013-03-12
• Results First Posted: 2013-04-24
• Status Verified: 2013-06
• Last Update Submitted: 2017-02-16
• Last Update Posted: 2017-03-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

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

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

1. No consent/inability to obtain consent
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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo tablet	Placebo	Placebo
Rosuvastatin (crestor)	Rosuvastatin (crestor)	Experimental arm

Primary Outcome Measures

Name	Time	Method
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).	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.

Trial Locations

Locations (21)

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

Johns Hopkins Hospital; 🇺🇸 Baltiomore, Maryland, United States

Moses H. Cone Memorial Hospital; 🇺🇸 Greensboro, North Carolina, United States

Erlanger; 🇺🇸 Chattanooga, Tennessee, United States

Mt Sinai; 🇺🇸 New York, New York, United States

Metro Health; 🇺🇸 Cleveland, Ohio, United States

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

University of Arkansas; 🇺🇸 Little Rock, Alaska, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Stanford; 🇺🇸 Stanford, California, United States

Maricopa Integrated Health System; 🇺🇸 Phoenix, Arizona, United States

Baystate Medical Center; 🇺🇸 Springfiled, Massachusetts, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States

Columbia University; 🇺🇸 New York, New York, United States

Intermountain; 🇺🇸 Murray, Utah, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

University of Texas; 🇺🇸 San Antonio, Texas, United States

Boston University; 🇺🇸 Boston, Massachusetts, United States

University of Oregon; 🇺🇸 Portland, Oregon, United States