Acute Respiratory Distress Syndrome, H1N1 Influenza, Influenza
Conditions
Keywords
ARDS, H1N1, Influenza, Statin
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.
Interventions
20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge
DRUGPlacebo
Placebo tablet identical to active therapy. 1 tablet per day
Sponsors
Gordon Bernard
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). | 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. |
Countries
United States
Participant flow
Recruitment details
Study terminated due to lack of recruitment due to earlier than anticipated end to H1N1 flu season
Participants by arm
| Arm | Count |
|---|---|
| Placebo Tablet Placebo
Placebo : Placebo tablet identical to active therapy. 1 tablet per day | 4 |
| Rosuvastatin (Crestor) Experimental arm
Rosuvastatin (crestor) : 20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge | 3 |
| Total | 7 |
Baseline characteristics
| Characteristic | Rosuvastatin (Crestor) | Placebo Tablet | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 4 Participants | 7 Participants |
| Age, Continuous | 39.88 years STANDARD_DEVIATION 5.32 | 43.03 years STANDARD_DEVIATION 12.89 | 41.68 years STANDARD_DEVIATION 9.76 |
| Region of Enrollment United States | 3 participants | 4 participants | 7 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 4 | 0 / 3 |
| serious Total, serious adverse events | 0 / 4 | 0 / 3 |
Outcome results
Primary
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.
Time frame: 28 days
Population: Only 7 participants were enrolled in this study designed for \>2000. No formal anlaysis of outcomes was performed as tne n was too small to show any differences