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STIP: Statin Trial for Influenza Patients (STIP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Gordon Bernard, Vanderbilt University Medical Center

Tracking Information
First Submitted Date  ICMJE August 31, 2009
First Posted Date  ICMJE September 2, 2009
Results First Submitted Date  ICMJE March 12, 2013
Results First Posted Date  ICMJE April 24, 2013
Last Update Posted Date March 22, 2017
Study Start Date  ICMJE October 2009
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 1, 2009)
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 ]
Change History Complete list of historical versions of study NCT00970606 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2009)
  • Ventilator free days [ Time Frame: 28 days ]
  • Survival (time to death) [ Time Frame: 28 days ]
  • ICU free days [ Time Frame: 28 days ]
  • Hospital free days [ Time Frame: 28 days ]
  • Shock free days [ Time Frame: 14 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE STIP: Statin Trial for Influenza Patients
Official Title  ICMJE Randomized, Placebo Controlled Trial of the Effectiveness of Statins for Preventing Mortality Following ICU Admission for Influenza Complications
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Respiratory Distress Syndrome
  • Influenza
  • H1N1 Influenza
Intervention  ICMJE
  • Drug: Rosuvastatin (crestor)
    20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge
    Other Name: Crestor
  • Drug: Placebo
    Placebo tablet identical to active therapy. 1 tablet per day
    Other Name: Placebo, sugar pill
Study Arms  ICMJE
  • Placebo Comparator: Placebo tablet
    Placebo
    Intervention: Drug: Placebo
  • Experimental: Rosuvastatin (crestor)
    Experimental arm
    Intervention: Drug: Rosuvastatin (crestor)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 29, 2011)
7
Original Estimated Enrollment  ICMJE
 (submitted: September 1, 2009)
2000
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00970606
Other Study ID Numbers  ICMJE STIP
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gordon Bernard, Vanderbilt University Medical Center
Study Sponsor  ICMJE Gordon Bernard
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gordon R Bernard, M.D. Vanderbilt University
PRS Account Vanderbilt University Medical Center
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP