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Impact of Statins on Cytokine Expression in Pneumonia

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. Identifier: NCT00946166
Recruitment Status : Withdrawn (Investigator left institution.)
First Posted : July 24, 2009
Last Update Posted : April 22, 2015
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

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 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 or disease Intervention/treatment Phase
Community Acquired Pneumonia Cardiovascular Risk Factors Drug: simvastatin Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Impact of Statins on Cytokine Expression in Pneumonia
Study Start Date : July 2009
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Simvastatin

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Cytokine (TNF alpha, IL-1beta, IL-6, IL-8, IL-10) levels [ Time Frame: enrollment, 24h, 48h, 72h, hospital discharge ]

Secondary Outcome Measures :
  1. 30-day mortality [ Time Frame: 30-days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00946166

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United States, Texas
Audie L Murphy Memorial Veterans Hospital
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
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Principal Investigator: Eric M Mortensen, MD University of Texas Health Science Center/ South Texas Veterans Health Care System
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Responsible Party: The University of Texas Health Science Center at San Antonio Identifier: NCT00946166    
Other Study ID Numbers: HSC2009-183H
First Posted: July 24, 2009    Key Record Dates
Last Update Posted: April 22, 2015
Last Verified: April 2015
Keywords provided by The University of Texas Health Science Center at San Antonio:
Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors