STIP: Statin Trial for Influenza Patients

NCT00970606 | Terminated Results DMC

• 1 other identifier: STIP
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 21

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.

Conditions

Acute Respiratory Distress Syndrome; Influenza; H1N1 Influenza

Keywords

ARDS; H1N1; Influenza; Statin

Outcome Measures

Primary Outcomes (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).

  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

Study Arms (2)

Placebo tablet

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Rosuvastatin (crestor)

EXPERIMENTAL

Experimental arm

Drug: Rosuvastatin (crestor)

Interventions

Rosuvastatin (crestor) DRUG

20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge

Also known as: Crestor

Rosuvastatin (crestor)

Placebo DRUG

Placebo tablet identical to active therapy. 1 tablet per day

Also known as: Placebo, sugar pill

Placebo tablet

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Gordon Bernard: lead

Study Sites (21)

University of Arkansas

Little Rock, Alaska, United States

Location

Maricopa Integrated Health System

Phoenix, Arizona, United States

Location

Stanford

Stanford, California, United States

Location

Northwestern University

Chicago, Illinois, United States

Location

University of Iowa

Iowa City, Iowa, United States

Location

Johns Hopkins Hospital

Baltiomore, Maryland, United States

Location

Boston University

Boston, Massachusetts, United States

Location

Baystate Medical Center

Springfiled, Massachusetts, United States

Location

Columbia University

New York, New York, United States

Location

Mt Sinai

New York, New York, United States

Location

Moses H. Cone Memorial Hospital

Greensboro, North Carolina, 27401, United States

Location

Metro Health

Cleveland, Ohio, United States

Location

Ohio State University

Columbus, Ohio, United States

Location

University of Oregon

Portland, Oregon, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Location

Medical University of South Carolina

Charleston, South Carolina, United States

Location

Erlanger

Chattanooga, Tennessee, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

University of Texas

San Antonio, Texas, United States

Location

Intermountain

Murray, Utah, United States

Location

University of Virginia

Charlottesville, Virginia, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome; Influenza, Human; Orthomyxoviridae Infections

Interventions

Rosuvastatin Calcium; Sugars

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbohydrates

Limitations and Caveats

Only able to enroll only 7 participants of \>2000 planned/anticipated, leading to early termination of the study and therefore unable to perform statistical analysis with such a small sample size.

Results Point of Contact

• Title: Gordon R. Bernard, MD, Associate Vice Chancellor for Research
• Organization: Vanderbilt University Medical Center

gordon.bernard@vanderbilt.edu

615-343-0077

Study Officials

• Gordon R Bernard, M.D.

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: August 31, 2009
• First Posted: September 2, 2009
• Study Start: October 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: March 22, 2017
• Results First Posted: April 24, 2013

Record last verified: 2013-06

Locations

US (21)