Statin Therapy in Acute Influenza
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Change in Inflammatory Markers From Time Zero to 72 Hours
研究概览
简要总结
Influenza (the 'flu') is a common virus infecting approximately 5-20% of the population in the United States and causing as many as 500,000 deaths worldwide each year. Currently, there are only a few treatments for influenza infection and none of these target inflammation that can be caused by the virus. This study will test whether the anti-inflammatory effects of statins, a class of drugs most often used to treat high cholesterol, will decrease the severity of illness in patients who are infected with influenza by testing markers of inflammation in the blood and recording resolution of influenza illness.
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
- Triple (Participant, Care Provider, Investigator)
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
- •(all must be present):
- •Adult patient (age > 18 years)
- •Positive influenza DFA/RAT test result
- •<12 hours from positive influenza test result
排除标准
- •Prior statin medication use (within 30 days of positive influenza test result)
- •Comfort measures only designation or anticipated withdrawal of life-support
- •Atorvastatin specific exclusions:
- •Documented liver cirrhosis or liver dysfunction (AST or ALT greater than 240)
- •Known allergy or intolerance to statins
- •Rhabdomyolysis (CPK elevation > 6x normal)
- •Patients taking the following medications: cyclosporine, HIV protease inhibitors, hepatitis C protease inhibitor telaprevir, fibric acid derivatives (gemfibrozil), niacin, azole antifungals (itraconazole, ketoconazole) clarithromycin and colchicine
- •Patients unable to take oral or nasogastric medications or plan for no oral intake as part of medical course (eg. emergent surgical intervention)
- •Known pregnancy or active breastfeeding
- •Inability to provide written informed consent for any reason
研究组 & 干预措施
Atorvastatin
Patients will be administered study medication (atorvastatin 40 mg) orally once daily for 5 days, for a maximum of 7 days for those who remain hospitalized.
干预措施: Atorvastatin (Drug)
Placebo
Patients will be administered study medication (matched placebo) orally once daily for 5 days, for a maximum of 7 days for those who remain hospitalized.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Inflammatory Markers From Time Zero to 72 Hours
时间窗: Baseline to 72 hours
The primary IL- 6 measurements were at time zero and at 72 hours. Analysis was performed using a linear mixed effects model to make use of all biomarker timepoints as hospitalized patients had biomarkers measured at additional timepoints.
次要结局
- Severity of Illness Score Baseline to 72 Hours(Baseline and 72 hours)
研究者
Maureen Chase MD MPH, Principal Investigator
Maureen Chase MD MPH
Beth Israel Deaconess Medical Center