A Phase II, Multicenter, Randomized, Placebo -Controlled, Study To Evaluate The Efficacy and Safety Of Intramuscular Peramivir 600 mg In Subjects With Uncomplicated Acute Influenza
Condition: Acute, Uncomplicated Human Influenza
MeSH terms: Influenza, Human
Intervention: Peramivir; Placebo
Intervention description: 600 mg peramivir administered as bilateral 2-mL intramuscular injection; Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
Intervention MeSH terms: Peramivir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 405.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether peramivir is safe and effective in the
      treatment of uncomplicated seasonal influenza.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and non-pregnant female subjects age ≥18 years.

          -  A positive Influenza A or B Rapid Antigen Test (RAT) performed with a commercially
             available test kit on an adequate anterior nasal specimen, in accordance with the
             manufacturer's instructions. A negative initial RAT should be repeated within one
             hour.

          -  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. A subject self-report of a history of fever or
             feverishness within the 24 hours prior to screening will also qualify for enrollment
             in the absence of documented fever at the time of screening.

          -  Presence of at least one respiratory symptom (cough, sore throat, or nasal symptoms)
             of at least moderate severity.

          -  Presence of at least one constitutional symptom (myalgia [aches and pains], headache,
             feverishness, or fatigue) of at least moderate severity.

          -  Onset of symptoms no more than 36 hours before presentation for screening.

          -  Written informed consent.

        Exclusion Criteria:

          -  Women who are pregnant or breast-feeding.

          -  Presence of clinically significant signs of acute respiratory distress

          -  History of severe chronic obstructive pulmonary disease (COPD) or severe persistent
             asthma.

          -  History of heart failure or angina requiring daily pharmacotherapy with symptoms
             consistent with New York Heart Association Class III or IV functional status within
             the past 12 months.

          -  Screening ECG which suggests acute ischemia or presence of medically significant
             dysrhythmia.

          -  History of chronic renal impairment requiring hemodialysis and/or known or suspected
             to have moderate or severe renal impairment (actual or estimated creatinine clearance
             <50 mL/min).

          -  Clinical evidence of worsening of any chronic medical condition (temporally associated
             with the onset of symptoms of influenza) which, in the investigator's opinion,
             indicates that such finding(s) could represent complications of influenza.

          -  Current clinical evidence, including clinical signs and/or symptoms consistent with
             otitis, bronchitis, sinusitis and/or pneumonia, or active bacterial infection at any
             body site that requires therapy with oral or systemic antibiotics.

          -  Presence of immunocompromised status due to chronic illness, previous organ
             transplant, or use of immunosuppressive medical therapy which would include oral or
             systemic treatment with > 10 mg prednisone or equivalent on a daily basis within 30
             days of screening.

          -  Currently receiving treatment for viral hepatitis B or viral hepatitis C.

          -  Presence of known HIV infection with a CD4 count <350 cell/mm3.

          -  Current therapy with oral warfarin or other systemic anticoagulant.

          -  Receipt of any doses of rimantadine, amantadine, zanamivir, or oseltamivir in the 7
             days prior to screening.

          -  Immunized against influenza with live attenuated virus vaccine (FluMist®) in the
             previous 21 days.

          -  Immunized against influenza with inactivated virus vaccine within the previous 14
             days.

          -  Receipt of any intramuscular injection with the previous 7 days.

          -  History of alcohol abuse or drug addiction within 1 year prior to admission in the
             study.

          -  Participation in a previous study of intramuscular or intravenous peramivir or
             previous participation in this study.

          -  Participation in a study of any investigational drug or device within the last 30
             days.