Clinical trial NCT00946166: Impact of Statins on Cytokine Expression in Pneumonia
Official title: Impact of Statins on Cytokine Expression in Pneumonia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Community Acquired Pneumonia
Cardiovascular Risk Factors
Keywords: pneumonia
statins
cytokines
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2009-07-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Cytokine (TNF alpha, IL-1beta, IL-6, IL-8, IL-10) levels
timeFrame: enrollment, 24h, 48h, 72h, hospital discharge
Secondary outcomes:
measure: 30-day mortality
timeFrame: 30-days
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Audie L Murphy Memorial Veterans Hospital
state: Texas
Study officials:
affiliation: University of Texas Health Science Center/ South Texas Veterans Health Care System
name: Eric M Mortensen, MD
role: PRINCIPAL_INVESTIGATOR
References: