Impact of Statins on Cytokine Expression in Pneumonia

Cardiovascular Risk Factors Clinical Trial

Official title:

Impact of Statins on Cytokine Expression in Pneumonia

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00946166
• Other study ID #: HSC2009-183H
• Status: Withdrawn
• Phase: Phase 4
• First received: July 22, 2009
• Last updated: April 20, 2015
• Start date: July 2009
• Est. completion date: August 2011

Study information

• Verified date: April 2015
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Risk Factors
• Community Acquired Pneumonia
• Pneumonia

Intervention

Drug:
• simvastatin
40 mg daily in the evening for a maximum of 14 days
• Placebo
Simvastatin-like placebo administered daily in the evening for a maximum of 14 days

Locations

Country	Name	City	State
United States	Audie L Murphy Memorial Veterans Hospital	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cytokine (TNF alpha, IL-1beta, IL-6, IL-8, IL-10) levels		enrollment, 24h, 48h, 72h, hospital discharge	No
Secondary	30-day mortality		30-days	No