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| Sponsor: | Vanderbilt University |
|---|---|
| Information provided by: | 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: | Treatment, Randomized, Double Blind (Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Randomized, Placebo Controlled Trial of the Effectiveness of Statins for Preventing Mortality Following ICU Admission for Influenza Complications |
| Estimated Enrollment: | 2000 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | October 2010 |
| Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo tablet: Placebo Comparator
Placebo
|
Drug: Placebo
Placebo tablet identical to active therapy. 1 tablet per day
|
|
Rosuvastatin (crestor): Experimental
Experimental arm
|
Drug: Rosuvastatin (crestor)
20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge
|
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 |
Inclusion Criteria:
Requirement for ICU (or ICU step-down) admission due to respiratory distress defined as:
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:
Contacts and Locations| Contact: Gordon R Bernard, M.D. | 615-343-0077 | gordon.bernard@vanderbilt.edu |
| Contact: Tonya R. Yarbrough, R.N. | 615-.343-8155 | tonya.yarbrough@vanderbilt.edu |
| United States, Arizona | |
| Maricopa Integrated Health System | Recruiting |
| Phoenix, Arizona, United States | |
| Contact: Carlson | |
| Principal Investigator: Richard Carlson | |
| United States, California | |
| Stanford | Terminated |
| Stanford, California, United States | |
| United States, Illinois | |
| Northwestern University | Recruiting |
| Chicago, Illinois, United States | |
| Contact: Richard Wunderink | |
| Principal Investigator: Richard Wunderink | |
| United States, Iowa | |
| University of Iowa | Recruiting |
| Iowa City, Iowa, United States | |
| Contact: Kevin Doerschug | |
| Principal Investigator: Kevin Doerschug | |
| United States, Maryland | |
| Johns Hopkins Hospital | Recruiting |
| Baltiomore, Maryland, United States | |
| Contact: Hager | |
| Principal Investigator: David Hager | |
| United States, Massachusetts | |
| Boston University | Recruiting |
| Boston, Massachusetts, United States | |
| Contact: Theodore | |
| Principal Investigator: Arthur Theodore | |
| Baystate Medical Center | Recruiting |
| Springfiled, Massachusetts, United States | |
| Contact: Steingrub | |
| Principal Investigator: Jay Steingrub | |
| United States, North Carolina | |
| Moses H. Cone Memorial Hospital | Recruiting |
| Greensboro, North Carolina, United States, 27401 | |
| Principal Investigator: Patrick Wright, MD | |
| United States, Ohio | |
| Ohio State University | Recruiting |
| Columbus, Ohio, United States | |
| Contact: Exline | |
| Principal Investigator: Matthew Exline | |
| Metro Health | Recruiting |
| Cleveland, Ohio, United States | |
| Contact: Thornton | |
| Principal Investigator: J. Daryl Thornton | |
| United States, Oregon | |
| University of Oregon | Recruiting |
| Portland, Oregon, United States | |
| Contact: Daniel Hagg | |
| Principal Investigator: Daniel Hagg | |
| United States, Pennsylvania | |
| University of Pittsburgh | Recruiting |
| Pittsburgh, Pennsylvania, United States | |
| Contact: Woodske | |
| Principal Investigator: Matthew Woodske | |
| United States, Tennessee | |
| Vanderbilt University | Recruiting |
| Nashville, Tennessee, United States, 37232 | |
| Contact: Bernard 615-343-0077 | |
| Contact: Tonya R Yarbrough, RN 615-343-8155 tonya.yarbrough@vanderbilt.edu | |
| Principal Investigator: Arthur P Wheeler, M.D. | |
| Erlanger | Recruiting |
| Chattanooga, Tennessee, United States | |
| Contact: Boldt | |
| Principal Investigator: John Boldt | |
| United States, Virginia | |
| University of Virginia | Recruiting |
| Charlottesville, Virginia, United States | |
| Contact: Truwit | |
| Principal Investigator: Jon Truwit | |
| Sub-Investigator: Douglas Wilson | |
| Principal Investigator: | Gordon R Bernard, M.D. | Vanderbilt University |
More Information
| Responsible Party: | Vanderbilt University ( Gordon R. Bernard, M.D. ) |
| Study ID Numbers: | STIP |
| Study First Received: | August 31, 2009 |
| Last Updated: | January 18, 2010 |
| ClinicalTrials.gov Identifier: | NCT00970606 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
ARDS H1N1 Influenza Statin |
|
Antimetabolites RNA Virus Infections Disease Molecular Mechanisms of Pharmacological Action Antilipemic Agents Respiratory Distress Syndrome, Adult Respiration Disorders Enzyme Inhibitors Anticholesteremic Agents Orthomyxoviridae Infections Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Pharmacologic Actions Virus Diseases Pathologic Processes Rosuvastatin Respiratory Tract Infections Respiratory Tract Diseases Therapeutic Uses Syndrome Lung Diseases Influenza, Human |