Evaluation of the Efficacy and Safety of Peramivir in Subjects With Uncomplicated Acute Influenza.

Inclusion Criteria:

• Age ≥18 years
• Presence of fever at time of screening of ≥38.0 ºC (≥100.4 ºF) taken orally, or ≥38.5 ºC (≥101.2 ºF) taken rectally. However, this requirement is waived if the subject has a history of fever within the 24 hours prior to screening and has been administered antipyretic(s) in the 6 hours prior to screening.
• Presence of at least one respiratory symptom (cough, sore throat, or nasal symptoms) of any severity (mild, moderate, or severe)
• Presence of at least one constitutional symptom (headache, malaise, myalgia, sweats and/or chills, or fatigue) of any severity (mild, moderate, or severe)
• Onset of illness no more than 48 hours before presentation. Note: Time of onset of illness is defined as either (1) the time when the temperature (either oral or rectal) was first measured as elevated (at least one ºC of elevation-oral temperature), OR (2) the time when the subject experienced the presence of at least one respiratory symptom AND the presence of at least one constitutional symptom.
• Rapid Antigen Test (RAT) performed on an adequate specimen collected from an anterior nasal swab is positive. A negative initial RAT may be repeated within one hour of obtaining a negative result. A second negative RAT result will exclude the subject from evaluation for enrollment.

• Females of childbearing potential must report one of the following:

  • Be surgically sterile
  • Have been sexually abstinent 4 weeks prior to date of screening evaluation and be willing to remain abstinent through 4 weeks after study drug administration
  • Use oral contraceptives or other form of hormonal birth control including hormonal vaginal rings or transdermal patches and have been using these for 3 months prior through 4 weeks after study drug administration
  • Use an intra-uterine device (IUD), or adequate barrier contraception (or double-barrier method such as condom or diaphragm with spermicidal gel or foam) as birth control 4 weeks prior to date of screening evaluation through 4 weeks after study drug administration.

Exclusion Criteria:

• Women who are breast-feeding
• History of diagnosed chronic obstructive pulmonary disease or diagnosis of severe persistent asthma
• History of chronic renal impairment requiring hemodialysis or known or suspected to have moderate or severe renal impairment (actual or estimated creatinine clearance <50 mL/min)
• History of congestive heart failure requiring daily pharmacotherapy with symptoms consistent with New York Heart Association Class II, III, or IV within the past 12 months
• Immunocompromised status due to illness or previous organ transplant
• Current use of systemic immunosuppressive medications (except inhaled corticosteroids)
• Use of rimantadine, amantadine, zanamivir, or oseltamivir in the past 7 days
• Immunized against influenza with live attenuated virus vaccine (FluMist®) in the previous 21 days
• Clinical evidence of active bacterial infection at any body site requiring therapy with oral or systemic antibiotics
• Clinically significant signs of acute respiratory distress
• Clinically significant signs of acute cardiac disease
• Screening ECG which suggests acute ischemia or presence of medically significant dysrhythmia
• Presence of a chronic disease or illness(es) with either clinical or historical evidence of recent exacerbation of such disease(s) or illness(es) or lack of control of such disease(s) or illness(es)
• History of hepatitis B, hepatitis C, or human immunodeficiency virus infection
• History of alcohol abuse or drug addiction within 1 year prior to admission in the study
• Participation in a study of any investigational drug within the last 30 days
• Positive urine pregnancy test