Impact of Statins on Cytokine Expression in Pneumonia

NCT00946166 | Withdrawn Phase 4

• 1 other identifier: HSC2009-183H
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

pneumonia; statins; cytokines

Outcome Measures

Primary Outcomes (1)

• Cytokine (TNF alpha, IL-1beta, IL-6, IL-8, IL-10) levels

  enrollment, 24h, 48h, 72h, hospital discharge

Secondary Outcomes (1)

• 30-day mortality

  30-days

Study Arms (2)

Placebo Control

PLACEBO COMPARATOR

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

Drug: Placebo

Simvastatin

EXPERIMENTAL

Subjects receive simvastatin in addition to standard pneumonia treatment

Drug: simvastatin

Interventions

simvastatin DRUG

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

Simvastatin

Placebo DRUG

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

Placebo Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

Audie L Murphy Memorial Veterans Hospital

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Community-Acquired Pneumonia; Pneumonia

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Eric M Mortensen, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2009
• First Posted: July 24, 2009
• Study Start: July 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: April 22, 2015

Record last verified: 2015-04

Locations

US (1)