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STIP: Statin Trial for Influenza Patients
This study is currently recruiting participants.
Verified by Vanderbilt University, January 2010
First Received: August 31, 2009   Last Updated: January 18, 2010   History of Changes
Sponsor: Vanderbilt University
Information provided by: Vanderbilt University
ClinicalTrials.gov Identifier: NCT00970606
  Purpose

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
Influenza
H1N1 Influenza
Drug: Rosuvastatin (crestor)
Drug: Placebo

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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: Yes ]

Secondary Outcome Measures:
  • Ventilator free days [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Survival (time to death) [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • ICU free days [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Hospital free days [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Shock free days [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2000
Study Start Date: October 2009
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo tablet: Placebo Comparator
Placebo
Drug: Placebo
Placebo tablet identical to active therapy. 1 tablet per day
Rosuvastatin (crestor): Experimental
Experimental arm
Drug: Rosuvastatin (crestor)
20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge

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.

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00970606

Contacts
Contact: Gordon R Bernard, M.D. 615-343-0077 gordon.bernard@vanderbilt.edu
Contact: Tonya R. Yarbrough, R.N. 615-.343-8155 tonya.yarbrough@vanderbilt.edu

Locations
United States, Arizona
Maricopa Integrated Health System Recruiting
Phoenix, Arizona, United States
Contact: Carlson            
Principal Investigator: Richard Carlson            
United States, California
Stanford Terminated
Stanford, California, United States
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States
Contact: Richard Wunderink            
Principal Investigator: Richard Wunderink            
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States
Contact: Kevin Doerschug            
Principal Investigator: Kevin Doerschug            
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltiomore, Maryland, United States
Contact: Hager            
Principal Investigator: David Hager            
United States, Massachusetts
Boston University Recruiting
Boston, Massachusetts, United States
Contact: Theodore            
Principal Investigator: Arthur Theodore            
Baystate Medical Center Recruiting
Springfiled, Massachusetts, United States
Contact: Steingrub            
Principal Investigator: Jay Steingrub            
United States, North Carolina
Moses H. Cone Memorial Hospital Recruiting
Greensboro, North Carolina, United States, 27401
Principal Investigator: Patrick Wright, MD            
United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States
Contact: Exline            
Principal Investigator: Matthew Exline            
Metro Health Recruiting
Cleveland, Ohio, United States
Contact: Thornton            
Principal Investigator: J. Daryl Thornton            
United States, Oregon
University of Oregon Recruiting
Portland, Oregon, United States
Contact: Daniel Hagg            
Principal Investigator: Daniel Hagg            
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States
Contact: Woodske            
Principal Investigator: Matthew Woodske            
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37232
Contact: Bernard     615-343-0077        
Contact: Tonya R Yarbrough, RN     615-343-8155     tonya.yarbrough@vanderbilt.edu    
Principal Investigator: Arthur P Wheeler, M.D.            
Erlanger Recruiting
Chattanooga, Tennessee, United States
Contact: Boldt            
Principal Investigator: John Boldt            
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States
Contact: Truwit            
Principal Investigator: Jon Truwit            
Sub-Investigator: Douglas Wilson            
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Gordon R Bernard, M.D. Vanderbilt University
  More Information

No publications provided

Responsible Party: Vanderbilt University ( Gordon R. Bernard, M.D. )
Study ID Numbers: STIP
Study First Received: August 31, 2009
Last Updated: January 18, 2010
ClinicalTrials.gov Identifier: NCT00970606     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Vanderbilt University:
ARDS
H1N1
Influenza
Statin

Additional relevant MeSH terms:
Antimetabolites
RNA Virus Infections
Disease
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Respiratory Distress Syndrome, Adult
Respiration Disorders
Enzyme Inhibitors
Anticholesteremic Agents
Orthomyxoviridae Infections
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Virus Diseases
Pathologic Processes
Rosuvastatin
Respiratory Tract Infections
Respiratory Tract Diseases
Therapeutic Uses
Syndrome
Lung Diseases
Influenza, Human

ClinicalTrials.gov processed this record on February 08, 2010