Acute Respiratory Distress SyndromeSTIPNCT00970606
STIP: Statin Trial for Influenza Patients
A study testing Rosuvastatin (crestor) in people with Acute Respiratory Distress Syndrome and Influenza, run by Gordon Bernard at 21 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Influenza, H1N1 Influenza
- What is being tested?
- Rosuvastatin (crestor)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 21 sitesUnited States
- Study dates
- Oct 2009to Jul 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Johns Hopkins Hospital
Baltiomore, Maryland
Boston University
Boston, Massachusetts
Medical University of South Carolina
Charleston, South Carolina
University of Virginia
Charlottesville, Virginia
Erlanger
Chattanooga, Tennessee
Northwestern University
Chicago, Illinois
Metro Health
Cleveland, Ohio
Ohio State University
Columbus, Ohio
Moses H. Cone Memorial Hospital
Greensboro, North Carolina, 27401
University of Iowa
Iowa City, Iowa
University of Arkansas
Little Rock, Alaska
Intermountain
Murray, Utah
Vanderbilt University
Nashville, Tennessee, 37232
Columbia University
New York, New York
Mt Sinai
New York, New York
Maricopa Integrated Health System
Phoenix, Arizona
University of Pittsburgh
Pittsburgh, Pennsylvania
University of Oregon
Portland, Oregon
University of Texas
San Antonio, Texas
Baystate Medical Center
Springfiled, Massachusetts
Stanford
Stanford, California
About this study
Official title: Randomized, Placebo Controlled Trial of the Effectiveness of Statins for Preventing Mortality Following ICU Admission for Influenza Complications
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.
Read the 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.
- Being tested
- Rosuvastatin (crestor), Placebo
- Keywords
- ARDS, H1N1, Influenza, Statin
- Medical subject headings
- Respiratory Distress Syndrome, Influenza, Human, Orthomyxoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosuvastatin (crestor)Drug
Also called Crestor
20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge
PlaceboDrug
Also called Placebo, sugar pill
Placebo tablet identical to active therapy. 1 tablet per day
| Study group | Role | What they receive |
|---|---|---|
| Placebo tablet | Placebo comparator | Placebo Receives: Drug: Placebo |
| Rosuvastatin (crestor) | Experimental | Experimental arm Receives: Drug: Rosuvastatin (crestor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2009 (estimated)
- Study startOct 2009
- Primary completionJul 2011
- Study completionJul 2011
Why it stopped: Inability to recruit participants since H1N1 epidemic resolved.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gordon Bernard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gordon Bernard, Vanderbilt University Medical Center
- Investigators
- Gordon R Bernard, M.D., Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00970606
- Sponsor's protocol ID
- STIP
- Acronym
- STIP
- Status last verified
- Jun 2013
- First submitted
- 31 Aug 2009
- Last updated
- 22 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Placebo Controlled Trial of the Effectiveness of Statins for Preventing Mortality Following ICU Admission for Influenza Complications
- ClinicalTrials.gov ID
- NCT00970606
- Acronym / sponsor ID
- STIP / STIP
- Keywords
- ARDS, H1N1, Influenza, Statin
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to recruit participants since H1N1 epidemic resolved.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Gordon BernardUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 2 Sep 2009 (estimated)
- Results
- Posted 24 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo tablet | Placebo comparator | Drug: PlaceboPlacebo |
| Rosuvastatin (crestor) | Experimental | Drug: Rosuvastatin (crestor)Experimental arm |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with suspected or confirmed influenza (Appendix A)
- 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.
Key exclusion criteria (11 listed)
- 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*
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rosuvastatin (crestor)Also: Crestor20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge | Drug | Rosuvastatin (crestor) |
| PlaceboAlso: Placebo, sugar pillPlacebo tablet identical to active therapy. 1 tablet per day | Drug | Placebo tablet |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gordon R Bernard, M.D. principal investigator
Vanderbilt University
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rosuvastatin (crestor) in people with Acute Respiratory Distress Syndrome and Influenza, run by Gordon Bernard at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2017.