STIP: Statin Trial for Influenza Patients
This study has been terminated.
(Inability to recruit participants since H1N1 epidemic resolved.)
Sponsor:
Gordon Bernard
Information provided by (Responsible Party):
Gordon Bernard, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00970606
First received: August 31, 2009
Last updated: June 28, 2013
Last verified: June 2013
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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:
Genetic and Rare Diseases Information Center resources:
Acute Respiratory Distress Syndrome
Heinz Body Anemias
Respiratory Distress Syndrome, Infant
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: No ]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 |
| 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00970606
Show 21 Study Locations
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
No publications provided
| Responsible Party: | Gordon Bernard, Vice Chancellor of Research, Vanderbilt University |
| 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: | June 28, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Vanderbilt University:
|
ARDS H1N1 Influenza Statin |
Additional relevant MeSH terms:
|
Acute Lung Injury Influenza, Human Respiratory Distress Syndrome, Adult Respiratory Distress Syndrome, Newborn Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases |
Lung Injury Orthomyxoviridae Infections RNA Virus Infections Respiration Disorders Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases |
ClinicalTrials.gov processed this record on March 03, 2015