Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Impact of Statins on Cytokine Expression in Pneumonia

This study has suspended participant recruitment.
Sponsor:
Information provided by:
The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT00946166
First received: July 22, 2009
Last updated: August 3, 2011
Last verified: August 2011
  Purpose

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 Intervention Phase
Community Acquired Pneumonia
Cardiovascular Risk Factors
Drug: simvastatin
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Impact of Statins on Cytokine Expression in Pneumonia

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:
  • Cytokine (TNF alpha, IL-1beta, IL-6, IL-8, IL-10) levels [ Time Frame: enrollment, 24h, 48h, 72h, hospital discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 30-day mortality [ Time Frame: 30-days ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: July 2009
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00946166

Locations
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
Investigators
Principal Investigator: Eric M Mortensen, MD University of Texas Health Science Center/ South Texas Veterans Health Care System
  More Information

No publications provided

Responsible Party: Eric M. Mortensen, MD, University of Texas Health Science Center San Antonio
ClinicalTrials.gov Identifier: NCT00946166     History of Changes
Other Study ID Numbers: HSC2009-183H
Study First Received: July 22, 2009
Last Updated: August 3, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center at San Antonio:
pneumonia
statins
cytokines

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Simvastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014