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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 Identifier:
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.

Condition Intervention
Acute Respiratory Distress Syndrome
H1N1 Influenza
Drug: Rosuvastatin (crestor)
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, 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

Resource links provided by NLM:

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

Enrollment: 7
Study Start Date: October 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo tablet
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

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.


Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00970606

  Hide Study Locations
United States, Alaska
University of Arkansas
Little Rock, Alaska, United States
United States, Arizona
Maricopa Integrated Health System
Phoenix, Arizona, United States
United States, California
Stanford, California, United States
United States, Illinois
Northwestern University
Chicago, Illinois, United States
United States, Iowa
University of Iowa
Iowa City, Iowa, United States
United States, Maryland
Johns Hopkins Hospital
Baltiomore, Maryland, United States
United States, Massachusetts
Boston University
Boston, Massachusetts, United States
Baystate Medical Center
Springfiled, Massachusetts, United States
United States, New York
Columbia University
New York, New York, United States
Mt Sinai
New York, New York, United States
United States, North Carolina
Moses H. Cone Memorial Hospital
Greensboro, North Carolina, United States, 27401
United States, Ohio
Metro Health
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
United States, Oregon
University of Oregon
Portland, Oregon, United States
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States
United States, Tennessee
Chattanooga, Tennessee, United States
Vanderbilt University
Nashville, Tennessee, United States, 37232
United States, Texas
University of Texas
San Antonio, Texas, United States
United States, Utah
Murray, Utah, United States
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States
Sponsors and Collaborators
Gordon Bernard
Principal Investigator: Gordon R Bernard, M.D. Vanderbilt University
  More Information

No publications provided

Responsible Party: Gordon Bernard, Vice Chancellor of Research, Vanderbilt University Identifier: NCT00970606     History of Changes
Other Study ID Numbers: STIP
Study First Received: August 31, 2009
Results First Received: March 12, 2013
Last Updated: June 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Vanderbilt University:

Additional relevant MeSH terms:
Acute Lung Injury
Influenza, Human
Respiratory Distress Syndrome, Adult
Respiratory Distress Syndrome, Newborn
Infant, Newborn, Diseases
Infant, Premature, Diseases
Lung Diseases
Lung Injury
Orthomyxoviridae Infections
RNA Virus Infections
Respiration Disorders
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases processed this record on March 03, 2015