Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2025-12-24 @ 4:04 PM
NCT ID:
NCT00946166
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00946166
Study Brief:
Protocol Section:
NCT00946166