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Impact of Statins on Cytokine Expression in Pneumonia

Primary Purpose

Community Acquired Pneumonia, Cardiovascular Risk Factors

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
simvastatin
Placebo
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Community Acquired Pneumonia focused on measuring pneumonia, statins, cytokines

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Audie L Murphy Memorial Veterans Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo Control

Simvastatin

Arm Description

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

Subjects receive simvastatin in addition to standard pneumonia treatment

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

30-day mortality

Full Information

First Posted
July 22, 2009
Last Updated
April 20, 2015
Sponsor
The University of Texas Health Science Center at San Antonio
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1. Study Identification

Unique Protocol Identification Number
NCT00946166
Brief Title
Impact of Statins on Cytokine Expression in Pneumonia
Official Title
Impact of Statins on Cytokine Expression in Pneumonia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Investigator left institution.
Study Start Date
July 2009 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center at San Antonio

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community Acquired Pneumonia, Cardiovascular Risk Factors
Keywords
pneumonia, statins, cytokines

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo Control
Arm Type
Placebo Comparator
Arm Description
Subjects receive standard treatment for pneumonia and a simvastatin-like placebo
Arm Title
Simvastatin
Arm Type
Experimental
Arm Description
Subjects receive simvastatin in addition to standard pneumonia treatment
Intervention Type
Drug
Intervention Name(s)
simvastatin
Intervention Description
40 mg daily in the evening for a maximum of 14 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Simvastatin-like placebo administered daily in the evening for a maximum of 14 days
Primary Outcome Measure Information:
Title
Cytokine (TNF alpha, IL-1beta, IL-6, IL-8, IL-10) levels
Time Frame
enrollment, 24h, 48h, 72h, hospital discharge
Secondary Outcome Measure Information:
Title
30-day mortality
Time Frame
30-days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric M Mortensen, MD
Organizational Affiliation
University of Texas Health Science Center/ South Texas Veterans Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Audie L Murphy Memorial Veterans Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

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Impact of Statins on Cytokine Expression in Pneumonia

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