STIP: Statin Trial for Influenza Patients

This study has been terminated.
(Inability to recruit participants since H1N1 epidemic resolved.)
Sponsor:
Information provided by (Responsible Party):
Gordon Bernard, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00970606
First received: August 31, 2009
Last updated: June 28, 2013
Last verified: June 2013

August 31, 2009
June 28, 2013
October 2009
July 2011   (final data collection date for primary outcome measure)
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.
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 ]
Complete list of historical versions of study NCT00970606 on ClinicalTrials.gov Archive Site
Not Provided
  • 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 ]
Not Provided
Not Provided
 
STIP: Statin Trial for Influenza Patients
Randomized, Placebo Controlled Trial of the Effectiveness of Statins for Preventing Mortality Following ICU Admission for Influenza Complications

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.

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Acute Respiratory Distress Syndrome
  • Influenza
  • H1N1 Influenza
  • 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
  • Placebo Comparator: Placebo tablet
    Placebo
    Intervention: Drug: Placebo
  • Experimental: Rosuvastatin (crestor)
    Experimental arm
    Intervention: Drug: Rosuvastatin (crestor)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
7
July 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00970606
STIP
Yes
Gordon Bernard, Vanderbilt University
Gordon Bernard
Not Provided
Principal Investigator: Gordon R Bernard, M.D. Vanderbilt University
Vanderbilt University
June 2013

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