Overview

Statin Therapy in Acute Influenza

Status:
Completed
Trial end date:
2018-06-30
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborator:
National Institute of General Medical Sciences (NIGMS)
Treatments:
Atorvastatin
Atorvastatin Calcium
Criteria
Inclusion Criteria:(all must be present):

1. Adult patient (age > 18 years)

2. Positive influenza DFA/RAT test result

3. <12 hours from positive influenza test result

Exclusion Criteria:

1. Prior statin medication use (within 30 days of positive influenza test result)

2. Comfort measures only designation or anticipated withdrawal of life-support

3. Atorvastatin specific exclusions:

1. Documented liver cirrhosis or liver dysfunction (AST or ALT greater than 240)

2. Known allergy or intolerance to statins

3. Rhabdomyolysis (CPK elevation > 6x normal)

4. 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

4. Patients unable to take oral or nasogastric medications or plan for no oral intake as
part of medical course (eg. emergent surgical intervention)

5. Known pregnancy or active breastfeeding

6. Inability to provide written informed consent for any reason