This is a study to evaluate the efficacy and safety of a single dose of intravenous peramivir versus placebo in adolescents and adults with acute uncomplicated influenza.
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a single dose of intravenous peramivir versus placebo in adolescents and adults with acute,uncomplicated influenza.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Adults (≥ 18 years): Peramivir 600 mg, administered intravenously. Adolescents (12 to \< 18 years): Peramivir 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously.
Placebo Peramivir, administered intravenously.
To evaluate the efficacy of peramivir administered intravenously compared to placebo on the time to alleviation of clinical symptoms with acute uncomplicated influenza.
Time to alleviation of clinical symptoms in adolescents and adults with uncomplicated acute influenza measured from patient reported study diaries.
Time frame: 14 Days
To evaluate the safety and tolerability of peramivir administered intravenously
To evaluate time to resolution of fever in response to treatment. To evaluate changes in influenza virus titer in nasal and pharyngeal samples (viral shedding) in response to treatment. To evaluate secondary clinical outcomes and changes in virus susceptibility to neuraminidase inhibitors in response to treatment.
Time frame: 14 Days
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Birmingham, Alabama, United States
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Hot Springs, Arkansas, United States
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Jonesboro, Arkansas, United States
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Little Rock, Arkansas, United States
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Mountain Home, Arkansas, United States
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Anaheim, California, United States
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Buena Park, California, United States
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Chino, California, United States
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Dinuba, California, United States
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Garden Grove, California, United States
...and 86 more locations