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STIP: Statin Trial for Influenza Patients (STIP)

Primary Purpose

Acute Respiratory Distress Syndrome, Influenza, H1N1 Influenza

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rosuvastatin (crestor)
Placebo
Sponsored by
Gordon Bernard
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Distress Syndrome focused on measuring ARDS, H1N1, Influenza, Statin

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Arkansas
  • Maricopa Integrated Health System
  • Stanford
  • Northwestern University
  • University of Iowa
  • Johns Hopkins Hospital
  • Boston University
  • Baystate Medical Center
  • Columbia University
  • Mt Sinai
  • Moses H. Cone Memorial Hospital
  • Metro Health
  • Ohio State University
  • University of Oregon
  • University of Pittsburgh
  • Medical University of South Carolina
  • Erlanger
  • Vanderbilt University
  • University of Texas
  • Intermountain
  • University of Virginia

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo tablet

Rosuvastatin (crestor)

Arm Description

Placebo

Experimental arm

Outcomes

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).
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.

Secondary Outcome Measures

Full Information

First Posted
August 31, 2009
Last Updated
February 16, 2017
Sponsor
Gordon Bernard
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1. Study Identification

Unique Protocol Identification Number
NCT00970606
Brief Title
STIP: Statin Trial for Influenza Patients
Acronym
STIP
Official Title
Randomized, Placebo Controlled Trial of the Effectiveness of Statins for Preventing Mortality Following ICU Admission for Influenza Complications
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Terminated
Why Stopped
Inability to recruit participants since H1N1 epidemic resolved.
Study Start Date
October 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gordon Bernard

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome, Influenza, H1N1 Influenza
Keywords
ARDS, H1N1, Influenza, Statin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo tablet
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
Rosuvastatin (crestor)
Arm Type
Experimental
Arm Description
Experimental arm
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin (crestor)
Other Intervention Name(s)
Crestor
Intervention Description
20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo, sugar pill
Intervention Description
Placebo tablet identical to active therapy. 1 tablet per day
Primary Outcome Measure Information:
Title
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).
Description
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.
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with suspected or confirmed influenza (Appendix A) 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: No consent/inability to obtain consent Age less than 13 years Weight less than 40 kg 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) Allergy or intolerance to statins* Pregnancy or breast feeding Receiving niacin, fenofibrate, cyclosporine, gemfibrozil, or any antiviral protease inhibitor including but not limited to lopinavir and ritonavir. Existing clinically significant myositis or myopathy or has a measured CK greater than 5,000 U/L Requiring statin for underlying disease as determined by the patients attending physician team**. Severe chronic liver disease (Child-Pugh Score 11-15) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gordon R Bernard, M.D.
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas
City
Little Rock
State/Province
Alaska
Country
United States
Facility Name
Maricopa Integrated Health System
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Stanford
City
Stanford
State/Province
California
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltiomore
State/Province
Maryland
Country
United States
Facility Name
Boston University
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Baystate Medical Center
City
Springfiled
State/Province
Massachusetts
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
Country
United States
Facility Name
Mt Sinai
City
New York
State/Province
New York
Country
United States
Facility Name
Moses H. Cone Memorial Hospital
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
Metro Health
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
University of Oregon
City
Portland
State/Province
Oregon
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Erlanger
City
Chattanooga
State/Province
Tennessee
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of Texas
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Intermountain
City
Murray
State/Province
Utah
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
Country
United States

12. IPD Sharing Statement

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STIP: Statin Trial for Influenza Patients

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