Impact of Statins on Cytokine Expression in Pneumonia

NCT ID: NCT00946166

Last Updated: 2015-04-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2011-08-31

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.

Conditions

Community Acquired Pneumonia; Cardiovascular Risk Factors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo Control

Subjects receive standard treatment for pneumonia and a simvastatin-like placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Simvastatin-like placebo administered daily in the evening for a maximum of 14 days

Simvastatin

Subjects receive simvastatin in addition to standard pneumonia treatment

Group Type: EXPERIMENTAL

simvastatin

Intervention Type: DRUG

40 mg daily in the evening for a maximum of 14 days

Interventions

simvastatin

40 mg daily in the evening for a maximum of 14 days

Intervention Type: DRUG

Placebo

Simvastatin-like placebo administered daily in the evening for a maximum of 14 days

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric M Mortensen, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Health Science Center/ South Texas Veterans Health Care System

Locations

Audie L Murphy Memorial Veterans Hospital

San Antonio, Texas, United States

Countries

United States

Other Identifiers

HSC2009-183H

Identifier Type: -

Identifier Source: org_study_id