STIP: Statin Trial for Influenza Patients (STIP)

This study has been terminated.

(Inability to recruit participants since H1N1 epidemic resolved.)

Sponsor:

Information provided by (Responsible Party):

Gordon Bernard, Vanderbilt University Medical Center

ClinicalTrials.gov Identifier:

NCT00970606

First received: August 31, 2009

Last updated: February 16, 2017

Last verified: June 2013

History of Changes

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 Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Flu Flu Shot Statins

Drug Information available for: Rosuvastatin calcium Rosuvastatin

Genetic and Rare Diseases Information Center resources: Respiratory Distress Syndrome, Infant Acute Respiratory Distress Syndrome

U.S. FDA Resources

Further study details as provided by Gordon Bernard, Vanderbilt University Medical Center:

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 ]
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.


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 (Child, Adult, Senior)
Sexes Eligible for Study:	All
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Show 21 Study Locations

Sponsors and Collaborators

Gordon Bernard

Investigators


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

More Information


Responsible Party:	Gordon Bernard, Professor of Medicine, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier:	NCT00970606 History of Changes
Other Study ID Numbers:	STIP
Study First Received:	August 31, 2009
Results First Received:	March 12, 2013
Last Updated:	February 16, 2017

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 Enzyme Inhibitors Lipid Regulating Agents

ClinicalTrials.gov processed this record on July 26, 2017

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