Clinical trial NCT02056340: Statin Therapy in Acute Influenza
Official title: Statin Therapy in Acute Influenza
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2014-02-06
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Change in Inflammatory Markers From Time Zero to 72 Hours
timeFrame: Baseline to 72 hours
Secondary outcomes:
measure: Severity of Illness Score Baseline to 72 Hours
timeFrame: Baseline and 72 hours
Other outcomes:
measure: Progression to Shock State
timeFrame: From date of randomization until discharge from hospital
measure: Severity of Illness
timeFrame: 24 hours post enrollment
measure: In-hospital Mortality
timeFrame: From date of randomization until the date of first documented discharge from hospital or date of death from any cause, whichever came first, assessed up to 1 year
measure: ICU and Hospital Length of Stay
timeFrame: From date of randomization until the date of ICU discharge (in the event of ICU admission) and/or hospital discharge, based on an estimated average of 30 days
Locations:
city: Boston
country: United States
facility: The Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Maureen Chase, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: