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STIP: Statin Trial for Influenza Patients (STIP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00970606
Recruitment Status : Terminated (Inability to recruit participants since H1N1 epidemic resolved.)
First Posted : September 2, 2009
Results First Posted : April 24, 2013
Last Update Posted : March 22, 2017
Sponsor:
Information provided by (Responsible Party):
Gordon Bernard, Vanderbilt University Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Acute Respiratory Distress Syndrome
Influenza
H1N1 Influenza
Interventions Drug: Rosuvastatin (crestor)
Drug: Placebo
Enrollment 7
Recruitment Details Study terminated due to lack of recruitment due to earlier than anticipated end to H1N1 flu season
Pre-assignment Details  
Arm/Group Title Placebo Tablet Rosuvastatin (Crestor)
Hide Arm/Group Description

Placebo

Placebo : Placebo tablet identical to active therapy. 1 tablet per day

Experimental arm

Rosuvastatin (crestor) : 20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge

Period Title: Overall Study
Started 4 3
Completed 4 3
Not Completed 0 0
Arm/Group Title Placebo Tablet Rosuvastatin (Crestor) Total
Hide Arm/Group Description

Placebo

Placebo : Placebo tablet identical to active therapy. 1 tablet per day

Experimental arm

Rosuvastatin (crestor) : 20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge

Total of all reporting groups
Overall Number of Baseline Participants 4 3 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 7 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
 100.0%
3
 100.0%
7
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 3 participants 7 participants
43.03  (12.89) 39.88  (5.32) 41.68  (9.76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 7 participants
Female
1
  25.0%
1
  33.3%
2
  28.6%
Male
3
  75.0%
2
  66.7%
5
  71.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 3 participants 7 participants
4 3 7
1.Primary Outcome
Title 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).
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Placebo Tablet Rosuvastatin (Crestor)
Hide Arm/Group Description:

Placebo

Placebo : Placebo tablet identical to active therapy. 1 tablet per day

Experimental arm

Rosuvastatin (crestor) : 20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 28 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Tablet Rosuvastatin (Crestor)
Hide Arm/Group Description

Placebo

Placebo : Placebo tablet identical to active therapy. 1 tablet per day

Experimental arm

Rosuvastatin (crestor) : 20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge

All-Cause Mortality
Placebo Tablet Rosuvastatin (Crestor)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Placebo Tablet Rosuvastatin (Crestor)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/4 (0.00%)      0/3 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Tablet Rosuvastatin (Crestor)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/4 (25.00%)      0/3 (0.00%)    
Hepatobiliary disorders     
Increased liver enzymes-AST/ALT *  1/4 (25.00%)  1 0/3 (0.00%)  0
*
Indicates events were collected by 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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gordon R. Bernard, MD, Associate Vice Chancellor for Research
Organization: Vanderbilt University Medical Center
Phone: 615-343-0077
EMail: gordon.bernard@vanderbilt.edu
Layout table for additonal information
Responsible Party: Gordon Bernard, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00970606    
Other Study ID Numbers: STIP
First Submitted: August 31, 2009
First Posted: September 2, 2009
Results First Submitted: March 12, 2013
Results First Posted: April 24, 2013
Last Update Posted: March 22, 2017