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STIP: Statin Trial for Influenza Patients

This study has been terminated.
(Inability to recruit participants since H1N1 epidemic resolved.)
Sponsor:
Information provided by (Responsible Party):
Gordon Bernard, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00970606
First received: August 31, 2009
Last updated: June 28, 2013
Last verified: June 2013
Results First Received: March 12, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Acute Respiratory Distress Syndrome
Influenza
H1N1 Influenza
Interventions: Drug: Rosuvastatin (crestor)
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study terminated due to lack of recruitment due to earlier than anticipated end to H1N1 flu season

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Tablet

Placebo

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

Rosuvastatin (Crestor)

Experimental arm

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


Participant Flow:   Overall Study
    Placebo Tablet     Rosuvastatin (Crestor)  
STARTED     4     3  
COMPLETED     4     3  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Tablet

Placebo

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

Rosuvastatin (Crestor)

Experimental arm

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

Total Total of all reporting groups

Baseline Measures
    Placebo Tablet     Rosuvastatin (Crestor)     Total  
Number of Participants  
[units: participants]
  4     3     7  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     4     3     7  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  43.03  ± 12.89     39.88  ± 5.32     41.68  ± 9.76  
Gender  
[units: participants]
     
Female     1     1     2  
Male     3     2     5  
Region of Enrollment  
[units: participants]
     
United States     4     3     7  



  Outcome Measures

1.  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).   [ Time Frame: 28 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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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:  
Name/Title: Gordon R. Bernard, MD, Associate Vice Chancellor for Research
Organization: Vanderbilt University Medical Center
phone: 615-343-0077
e-mail: gordon.bernard@vanderbilt.edu


No publications provided


Responsible Party: Gordon Bernard, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00970606     History of Changes
Other Study ID Numbers: STIP
Study First Received: August 31, 2009
Results First Received: March 12, 2013
Last Updated: June 28, 2013
Health Authority: United States: Food and Drug Administration