Impact of Statins on Cytokine Expression in Pneumonia

Phase 4

Withdrawn

• Conditions: Community Acquired Pneumonia; Cardiovascular Risk Factors
• Interventions: Drug: Placebo; Drug: simvastatin

• Registration Number: NCT00946166
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-22
• Study First Submitted QC: 2009-07-23
• Study First Posted: 2009-07-24
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-20
• Last Update Posted: 2015-04-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Control	Placebo	Subjects receive standard treatment for pneumonia and a simvastatin-like placebo
Simvastatin	simvastatin	Subjects receive simvastatin in addition to standard pneumonia treatment

Primary Outcome Measures

Name	Time	Method
Cytokine (TNF alpha, IL-1beta, IL-6, IL-8, IL-10) levels	enrollment, 24h, 48h, 72h, hospital discharge

Secondary Outcome Measures

Name	Time	Method
30-day mortality	30-days

Trial Locations

Locations (1)

Audie L Murphy Memorial Veterans Hospital; 🇺🇸 San Antonio, Texas, United States