Evaluation of the Efficacy and Safety of Peramivir in Subjects With Uncomplicated Acute Influenza.
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Peramivir 150 mg; Peramivir 300 mg; Placebo
Intervention description: Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).; Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).; Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
Intervention MeSH terms: Peramivir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 344.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: influenza; flu

Summary:

      This is a study for patients with flu who also have a fever as well as other flu symptoms.
      Patients must have had symptoms for less than 48 hours in order to participate. Patients will
      have two out of three chances of getting an active study treatment and the other third will
      receive a placebo (dummy drug). Nobody will know who gets the active drug and who gets the
      inactive drug. All patients will get supplies to treat symptoms of flu. Patients will need to
      be seen 5 more times after they are enrolled in the study.
    

Eligibility criteria:

        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