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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Influenza H1N1 Influenza Drug: Rosuvastatin (crestor) Drug: Placebo Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, 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
Study Start Date : October 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00970606


Locations
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Sponsors and Collaborators
Gordon Bernard
Investigators
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Principal Investigator: Gordon R Bernard, M.D. Vanderbilt University
More Information
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Responsible Party: Gordon Bernard, Professor of Medicine, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00970606    
Other Study ID Numbers: STIP
First Posted: September 2, 2009    Key Record Dates
Results First Posted: April 24, 2013
Last Update Posted: March 22, 2017
Last Verified: June 2013
Keywords provided by Gordon Bernard, Vanderbilt University Medical Center:
ARDS
H1N1
Influenza
Statin
Additional relevant MeSH terms:
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Influenza, Human
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders
 Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors