STIP: Statin Trial for Influenza Patients - Full Text View

Sponsor:	Vanderbilt University
Information provided by (Responsible Party):	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00970606

Purpose

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	Intervention
Acute Respiratory Distress Syndrome Influenza H1N1 Influenza	Drug: Rosuvastatin (crestor) Drug: Placebo

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Flu Statins

Drug Information available for: Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

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). [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Ventilator free days [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Survival (time to death) [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
ICU free days [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Hospital free days [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Shock free days [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Enrollment:	7
Study Start Date:	October 2009
Study Completion Date:	July 2011
Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	13 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00970606

Show 21 Study Locations

Sponsors and Collaborators

Vanderbilt University

Investigators

Principal Investigator:

Gordon R Bernard, M.D.

Vanderbilt University

More Information

No publications provided

Responsible Party:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00970606 History of Changes
Other Study ID Numbers:	STIP
Study First Received:	August 31, 2009
Last Updated:	November 29, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Vanderbilt University:

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
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012