Clinical trial NCT00970606: STIP: Statin Trial for Influenza Patients
Official title: Randomized, Placebo Controlled Trial of the Effectiveness of Statins for Preventing Mortality Following ICU Admission for Influenza Complications
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Respiratory Distress Syndrome
Influenza
H1N1 Influenza
Keywords: ARDS
H1N1
Influenza
Statin
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2009-09-02
Enrollment: 7
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 criteria: Inclusion Criteria:

1. Patients with suspected or confirmed influenza (Appendix A)
2. 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:

1. No consent/inability to obtain consent
2. Age less than 13 years
3. Weight less than 40 kg
4. 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)
5. Allergy or intolerance to statins\*
6. Pregnancy or breast feeding
7. Receiving niacin, fenofibrate, cyclosporine, gemfibrozil, or any antiviral protease inhibitor including but not limited to lopinavir and ritonavir.
8. Existing clinically significant myositis or myopathy or has a measured CK greater than 5,000 U/L
9. Requiring statin for underlying disease as determined by the patients attending physician team\*\*.
10. Severe chronic liver disease (Child-Pugh Score 11-15)
11. 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

Primary outcomes:
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).
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas
state: Alaska
city: Phoenix
country: United States
facility: Maricopa Integrated Health System
state: Arizona
city: Stanford
country: United States
facility: Stanford
state: California
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Baltiomore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Boston University
state: Massachusetts
city: Springfiled
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: New York
country: United States
facility: Columbia University
state: New York
city: New York
country: United States
facility: Mt Sinai
state: New York
city: Greensboro
country: United States
facility: Moses H. Cone Memorial Hospital
state: North Carolina
city: Cleveland
country: United States
facility: Metro Health
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Portland
country: United States
facility: University of Oregon
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Chattanooga
country: United States
facility: Erlanger
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: San Antonio
country: United States
facility: University of Texas
state: Texas
city: Murray
country: United States
facility: Intermountain
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: Vanderbilt University
name: Gordon R Bernard, M.D.
role: PRINCIPAL_INVESTIGATOR
References: