Status:
WITHDRAWN
Impact of Statins on Cytokine Expression in Pneumonia
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Conditions:
Community Acquired Pneumonia
Cardiovascular Risk Factors
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The investigators are conducting a study to determine the effects of a cholesterol-lowering medication, called simvastatin on pneumonia. People in the study will be in the hospital because they have p...
Eligibility Criteria
Inclusion
- At least 18 years of age,
- Chart documentation by a clinician of an initial working diagnosis of pneumonia within 24 hours of admission,
- Chest x-ray or other imaging evidence consistent with pneumonia within 48 hours of hospitalization, and
- One of the following severity criteria: pneumonia severity index class III or higher, at least 2/5 components of the CURB-65, or ICU level care within 24 hours of admission.
- Having one Food and Drug Agency approved indication for statin therapy
Exclusion
- Prior Treatment with one or more doses of a statin within 30-days prior to admission or during the current hospitalization.
- Hospitalization \> 24 hours at time of the diagnosis of pneumonia.
- Hospitalization \> 48 hours at time of study enrollment.
- Residence in a skilled nursing facility.
- Previously diagnosed human immunodeficiency virus infection with a current CD4 count \< 200 cells/mm.
- Immunosuppression
- Patient or family decision to limit medical care ("comfort measures only").
- Known allergy to statin therapy.
- Active or planned pregnancy or breastfeeding.
- Inability to take oral medications at the time of study enrollment.
- Pre-existing liver disease or AST/ALT \> 10% the upper limit of normal.
- Creatinine phosphokinase (CPK or CK) \> 50% above the upper limit of normal.
- Partial ileal bypass.
- Concurrent treatment with potential interacting drugs: ketoconazole, itraconazole, amiodarone, clarithromycin, erythromycin, cyclosporine, danazol, niacin, protease inhibitors, telithromycin, verapamil, gemfiborzil, ezetimibe (Zetia), nefazodone.
- Transfer from an outside hospital.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00946166
Start Date
July 1 2009
End Date
August 1 2011
Last Update
April 22 2015
Active Locations (1)
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1
Audie L Murphy Memorial Veterans Hospital
San Antonio, Texas, United States, 78229