The purpose of this study is to determine whether peramivir is safe and effective in the treatment of uncomplicated seasonal influenza.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
405
Time to Alleviation of Symptoms (Kaplan-Meier Estimate)
The primary efficacy endpoint was the time to alleviation of symptoms calculated as the number of hours from initiation of study drug until the start of the time period in which all 7 symptoms of influenza were either absent or present at a level no greater than mild for at least 21.5 (24 hours - 10%) hours. Subjects with missing diary data were excluded and those who did not experience alleviation of symptoms were censored at the last observed symptom assessment.
Time frame: Information collected twice daily beginning predose on Day 1 and through Day 9, then once daily through Day 14
Change in Influenza Virus Shedding
Changes from Baseline in log10 TCID50/mL through Days 3, 4, and 9 were presented by treatment group for subjects with positive viral titers at Baseline (log10 TCID50/mL \>0.5).
Time frame: Baseline and Days 3, 4, 9
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