Statin Therapy in Acute Influenza

Description

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.

Study Start Date

October 2013

Estimated Completion Date

December 2017

Interventions

  • Drug: Placebo
  • Drug: Atorvastatin

Specialties

  • Internal Medicine: Clinical Pharmacology,Infectious Disease,Pulmonology
  • Infectious Disease: Pulm/Thoracic Infections
  • Pulmonology: Clinical Pharmacology,Pulm/Thoracic Infections
  • Pharmacy: Other Drugs

MeSH Terms

  • Atorvastatin
  • Influenza
  • Statin

Study ID

Beth Israel Deaconess Medical Center -- 2013P000026

Status

Unknown

Trial ID

NCT02056340

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

174

Sponsor

Beth Israel Deaconess Medical Center

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
The Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.4 miles Maureen Chase MD MPH 617-754-2343 None

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