STIP: Statin Trial for Influenza Patients (STIP)

February 16, 2017 updated by: Gordon Bernard

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alaska
      • Little Rock, Alaska, United States
        • University of Arkansas
    • Arizona
      • Phoenix, Arizona, United States
        • Maricopa Integrated Health System
    • California
      • Stanford, California, United States
        • Stanford
    • Illinois
      • Chicago, Illinois, United States
        • Northwestern University
    • Iowa
      • Iowa City, Iowa, United States
        • University of Iowa
    • Maryland
      • Baltiomore, Maryland, United States
        • Johns Hopkins Hospital
    • Massachusetts
      • Boston, Massachusetts, United States
        • Boston University
      • Springfiled, Massachusetts, United States
        • Baystate Medical Center
    • New York
      • New York, New York, United States
        • Columbia University
      • New York, New York, United States
        • Mt Sinai
    • North Carolina
      • Greensboro, North Carolina, United States, 27401
        • Moses H. Cone Memorial Hospital
    • Ohio
      • Cleveland, Ohio, United States
        • Metro Health
      • Columbus, Ohio, United States
        • Ohio State University
    • Oregon
      • Portland, Oregon, United States
        • University of Oregon
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
        • University of Pittsburgh
    • South Carolina
      • Charleston, South Carolina, United States
        • Medical University of South Carolina
    • Tennessee
      • Chattanooga, Tennessee, United States
        • Erlanger
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University
    • Texas
      • San Antonio, Texas, United States
        • University of Texas
    • Utah
      • Murray, Utah, United States
        • Intermountain
    • Virginia
      • Charlottesville, Virginia, United States
        • University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo tablet
Placebo
Drug: Placebo
Placebo tablet identical to active therapy. 1 tablet per day
Other Names:
  • 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 Names:
  • Crestor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gordon Bernard

Investigators

  • Principal Investigator: Gordon R Bernard, M.D., Vanderbilt University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

August 31, 2009

First Submitted That Met QC Criteria

September 1, 2009

First Posted (Estimate)

September 2, 2009

Study Record Updates

Last Update Posted (Actual)

March 22, 2017

Last Update Submitted That Met QC Criteria

February 16, 2017

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STIP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Influenza

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe