Impact of Statins on Cytokine Expression in Pneumonia
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Purpose
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 pneumonia. The people will also have a medical condition like heart disease, diabetes, stroke or high cholesterol for which cholesterol-lowering medication has been shown to prevent future disease and/or death but are not taking a cholesterol-lowering medication when they go to the hospital. Some people will get treated with antibiotics only and other people will get antibiotics and simvastatin while they are in the hospital. The study will compare the effects the combination of simvastatin and antibiotics has on people with pneumonia to treatment with antibiotics alone.
| Condition | Intervention | Phase |
|---|---|---|
|
Community Acquired Pneumonia Cardiovascular Risk Factors |
Drug: simvastatin Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment |
| Official Title: | Impact of Statins on Cytokine Expression in Pneumonia |
- Cytokine (TNF alpha, IL-1beta, IL-6, IL-8, IL-10) levels [ Time Frame: enrollment, 24h, 48h, 72h, hospital discharge ] [ Designated as safety issue: No ]
- 30-day mortality [ Time Frame: 30-days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 24 |
| Study Start Date: | July 2009 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo Control
Subjects receive standard treatment for pneumonia and a simvastatin-like placebo
|
Drug: Placebo
Simvastatin-like placebo administered daily in the evening for a maximum of 14 days
|
|
Experimental: Simvastatin
Subjects receive simvastatin in addition to standard pneumonia treatment
|
Drug: simvastatin
40 mg daily in the evening for a maximum of 14 days
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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.
Contacts and Locations| United States, Texas | |
| Audie L Murphy Memorial Veterans Hospital | |
| San Antonio, Texas, United States, 78229 | |
| Principal Investigator: | Eric M Mortensen, MD | University of Texas Health Science Center/ South Texas Veterans Health Care System |
More Information
No publications provided
| Responsible Party: | Eric M. Mortensen, MD, University of Texas Health Science Center San Antonio |
| ClinicalTrials.gov Identifier: | NCT00946166 History of Changes |
| Other Study ID Numbers: | HSC2009-183H |
| Study First Received: | July 22, 2009 |
| Last Updated: | August 3, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by The University of Texas Health Science Center at San Antonio:
|
pneumonia statins cytokines |
Additional relevant MeSH terms:
|
Pneumonia Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Simvastatin Hypolipidemic Agents Antimetabolites |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Lipid Regulating Agents Therapeutic Uses Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 21, 2013