STIP: Statin Trial for Influenza Patients (STIP)

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

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, Senior)
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 21 Study Locations

Sponsors and Collaborators

Gordon Bernard

Investigators

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 History of Changes
Other Study ID Numbers:	STIP
First Posted:	September 2, 2009
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:

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 Calcium; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents; Enzyme Inhibitors