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
  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: 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
Placebo
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.

  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

  Show 21 Study Locations
Sponsors and Collaborators
Gordon Bernard
Investigators
Principal Investigator: Gordon R Bernard, M.D. Vanderbilt University
  More Information

No publications provided

Responsible Party: Gordon Bernard, Vice Chancellor of Research, Vanderbilt University
ClinicalTrials.gov 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:
ARDS
H1N1
Influenza
Statin

Additional relevant MeSH terms:
Influenza, Human
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Rosuvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2014