Impact of Statins on Cytokine Expression in Pneumonia
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Cytokine (TNF alpha, IL-1beta, IL-6, IL-8, IL-10) levels
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Placebo Control
Subjects receive standard treatment for pneumonia and a simvastatin-like placebo
干预措施: Placebo (Drug)
Simvastatin
Subjects receive simvastatin in addition to standard pneumonia treatment
干预措施: simvastatin (Drug)
结局指标
主要结局
Cytokine (TNF alpha, IL-1beta, IL-6, IL-8, IL-10) levels
时间窗: enrollment, 24h, 48h, 72h, hospital discharge
次要结局
- 30-day mortality(30-days)