Not provided
Not provided
Not provided
Not provided
Inability to recruit participants since H1N1 epidemic resolved.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Hypothesis: Rosuvastatin therapy will improve mortality and reduce the need for mechanical ventilation in patients experiencing respiratory distress as a complication of influenza.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo tablet | Placebo Comparator | Placebo |
|
| Rosuvastatin (crestor) | Experimental | Experimental arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin (crestor) | Drug | 20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 28 days |
Not provided
Not provided
Inclusion Criteria:
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.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gordon R Bernard, M.D. | Vanderbilt University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas | Little Rock | Alaska | United States | |||
| Maricopa Integrated Health System |
Not provided
Study terminated due to lack of recruitment due to earlier than anticipated end to H1N1 flu season
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Tablet | Placebo Placebo : Placebo tablet identical to active therapy. 1 tablet per day |
| FG001 | Rosuvastatin (Crestor) | Experimental arm Rosuvastatin (crestor) : 20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo tablet identical to active therapy. 1 tablet per day |
|
|
| Phoenix |
| Arizona |
| United States |
| Stanford | Stanford | California | United States |
| Northwestern University | Chicago | Illinois | United States |
| University of Iowa | Iowa City | Iowa | United States |
| Johns Hopkins Hospital | Baltiomore | Maryland | United States |
| Boston University | Boston | Massachusetts | United States |
| Baystate Medical Center | Springfiled | Massachusetts | United States |
| Columbia University | New York | New York | United States |
| Mt Sinai | New York | New York | United States |
| Moses H. Cone Memorial Hospital | Greensboro | North Carolina | 27401 | United States |
| Metro Health | Cleveland | Ohio | United States |
| Ohio State University | Columbus | Ohio | United States |
| University of Oregon | Portland | Oregon | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | United States |
| Medical University of South Carolina | Charleston | South Carolina | United States |
| Erlanger | Chattanooga | Tennessee | United States |
| Vanderbilt University | Nashville | Tennessee | 37232 | United States |
| University of Texas | San Antonio | Texas | United States |
| Intermountain | Murray | Utah | United States |
| University of Virginia | Charlottesville | Virginia | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Tablet | Placebo Placebo : Placebo tablet identical to active therapy. 1 tablet per day |
| BG001 | Rosuvastatin (Crestor) | Experimental arm Rosuvastatin (crestor) : 20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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 | Posted | 28 days |
|
|
28 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Tablet | Placebo Placebo : Placebo tablet identical to active therapy. 1 tablet per day | 0 | 4 | 1 | 4 | ||
| EG001 | Rosuvastatin (Crestor) | Experimental arm Rosuvastatin (crestor) : 20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge | 0 | 3 | 0 | 3 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased liver enzymes-AST/ALT | Hepatobiliary disorders | Non-systematic Assessment |
|
Only able to enroll only 7 participants of >2000 planned/anticipated, leading to early termination of the study and therefore unable to perform statistical analysis with such a small sample size.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gordon R. Bernard, MD, Associate Vice Chancellor for Research | Vanderbilt University Medical Center | 615-343-0077 | gordon.bernard@vanderbilt.edu |
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D007251 | Influenza, Human |
| D009976 | Orthomyxoviridae Infections |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002241 | Carbohydrates |
Not provided
Not provided
| >=65 years |
|
| Male |
|