| Criteria: |
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Inclusion Criteria:
- Age ≥12 years of age, male or female.
- Able to provide informed consent, or for whom consent may be provided by guardian,
unless informed consent provided by a guardian or a legally authorized representative
is not consistent with applicable local or ethical concerns, procedures, directives
and/or guidelines.
- Subject must have at least one of the following clinical presentations:
- Oral temperature > 38.0 °C (>100.0 °F), OR
- Oxygen saturation <92%, OR
- Two out of the following three vital signs:
- Respiration rate >24/minute
- Heart rate >100/minute
- Systolic BP <90 mmHg
- Presence of at least one respiratory symptom (cough, sore throat, or nasal
congestion) of any severity (mild, moderate, or severe).
- Presence of at least one constitutional symptom (headache, myalgia, feverishness, or
fatigue) of any severity (mild, moderate, or severe).
- Onset of illness no more than 72 hours before presentation. Note: Time of onset of
illness is defined as either (1) the time when the temperature was first measured as
elevated, 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.
- Either:Severity of illness that, in the Investigator's judgment, justifies
hospitalization of the subject for supportive care.
OR Presence of one or more of the following factors:
- Age ≥60 years.
- Presence of chronic obstructive pulmonary disease (COPD) or other chronic lung
disease requiring daily pharmacotherapy.
- Current history of congestive heart failure or angina.
- Presence of diabetes mellitus, clinically stable or unstable.
- Transcutaneous oxygen saturation <94% without supplemental oxygen for at least 5
minutes, or a medically significant decrease in oxygen saturation from an established
baseline value (an investigative site at altitude >2000 ft above sea level will
utilize different criteria for oxygen saturation).
- History of chronic renal impairment not requiring dialysis.
- Serum creatinine > 2.0 mg/dL.
- Diagnosis of Influenza by satisfying one of the following:
- Clinical Influenza with Positive Diagnostic Test. Subjects who have a positive rapid
antigen test (RAT) for influenza A and/or influenza B (using a Sponsor-approved test
kit), or positive test (using other methodology) for influenza A and/or B virus
antigen or RNA performed in a clinical laboratory at the screening/enrollment
evaluation are eligible for enrollment.
OR
- Clinical Influenza with Negative Rapid Antigen Test (RAT). Subjects with a negative
RAT or other clinical laboratory test may be enrolled once the site has been approved
by the Sponsor to enroll such subjects, based on documentation of an outbreak of
influenza in the community. An influenza outbreak may be documented in the catchment
area of the hospital via one of the following methods: 1) local confirmation of
influenza A or B infection in the current influenza season by a) the institution's
local laboratory, or b) the local public health system, or c) the national public
health system, or d) a laboratory of a recognized multinational influenza
surveillance scheme such as the European Influenza Surveillance Scheme (EISS); 2)
prior enrollment of a RAT positive subject into this study at the same institution in
the current influenza season.
- Females must fulfill one of the following conditions:
- Subject is surgically sterile or clinically post-menopausal.
- Subject has been sexually abstinent 4 weeks prior to date of screening evaluation and
is willing to remain abstinent through 4 weeks after study-drug administration.
- Subject has been using oral contraceptives or other form of hormonal birth control
including hormonal vaginal rings or transdermal patches for 3 months prior to the
study, and use will continue through 4 weeks after study-drug administration.
- Subject has been using an intra-uterine device, or adequate double-barrier method
such as condom or diaphragm with spermicidal gel or foam as birth control 4 weeks
prior to date of Screening evaluation, and use will continue through 4 weeks after
study drug administration.
- Males will ensure that their female partners of childbearing potential will utilize
approved contraceptive methods to avoid pregnancy.
Exclusion Criteria:
- Subjects who have developed clinical manifestations of influenza after having been
hospitalized for a condition other than confirmed or suspected influenza.
- Treatment with any dose(s) of rimantadine, amantadine, ribavirin, zanamivir, or
oseltamivir in the previous 7 days.
- Blood platelet count of < 20 x 109/L.
- Serum bilirubin > 6 mg/dL at time of screening evaluation.
- Serum ALT or AST > 5 times the upper limit of normal at time of screening evaluation.
- Congestive heart failure of NYHA Class III or Class IV functional status.
- Requirement for vasopressor support to maintain satisfactory hemodynamic status at
time of screening evaluation.
- Serum creatinine > 5.0 mg/dL at time of screening evaluation.
- Subjects who require peritoneal dialysis or hemofiltration.
- Altered neurologic status as defined by a Glasgow Coma Score of ≤ 9, unless medically
induced.
- Females who are pregnant (positive urine or serum pregnancy test at screening
evaluation) or lactating.
- Actively undergoing systemic chemotherapy or radiotherapy treatment for a malignancy.
- Prior hematopoietic stem cell transplantation or solid organ transplant during the
previous 4 months.
- HIV infection with a known CD4 count < 200 cells/mm3 unless on a stable highly
active antiretroviral regimen (HAART) for at least 6 months.
- Presence of a pre-existing chronic infection that is undergoing or requiring medical
therapy (eg, tuberculosis). Subjects with chronic osteomyelitis are not excluded.
- Presence of any pre-existing illness that, in the opinion of the investigator, would
place the subject at an unreasonably increased risk through participation in this
study.
- Previous treatment with intravenous or intramuscular peramivir.
- Participation as a subject in any study of an experimental treatment for any
condition within the 30 days prior to the time of the screening evaluation.
- Subjects who, in the judgment of the investigator, will be unlikely to comply with
the requirements of this protocol. |