ED Influenza Therapeutic Pilot Study: Oseltamivir vs. Peramivir
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Oseltamivir; Peramivir
Intervention description: Oral; IV
Note: Subjects admitted to the hospital directly from the ED Enrollment Visit may receive more doses at the discretion of the treating physician.
Intervention MeSH terms: Oseltamivir; Peramivir
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 180.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Influenza; Antiviral treatment; Emergency department; Influenza therapeutics; Rapid influenza testing

Summary:

      This pilot study is designed to demonstrate the feasibility of utilizing Emergency
      Departments (EDs) as a primary site for subject enrollment in clinical trials evaluating
      influenza therapeutics, and to provide pilot data for future clinical trial design and
      planning.

      Primary Objective: To prospectively enroll high-risk subjects with laboratory-confirmed
      influenza into a randomized, open label study of oral versus IV influenza therapeutic to
      include symptom evaluation and outcome assessments.

      Secondary Objective 1: To identify influenza positive patients utilizing a previously
      established triage-based assessment and rapid testing algorithm for suspected influenza
      infection.

      Secondary Objective 2: To retrospectively evaluate all potentially eligible patients for
      potential enrollment biases.

      Secondary Objective 3: To create a repository of residual nasopharyngeal samples collected
      from ED patients with suspected influenza illness.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eligible patients include all patients who present to the emergency department (ED)
             between November and April of each influenza season, or later, at the Co-PIs'
             discretion, based on influenza prevalence, with the following criteria:

               1. 18 years of age or older

               2. Laboratory confirmed positive influenza test associated with their current ED
                  visit

               3. Symptoms of acute respiratory illness for ≤4 days (96 hours)

               4. Meets CDC criteria for antiviral treatment

          -  For the purpose of this study, acute respiratory illness is defined as presence of any
             of the following symptoms: new or increased cough, new or increased shortness of
             breath, change in sputum production (for adults 65 years or older), sinus pain, nasal
             congestion, rhinorrhea, sore throat, subjective fever reported at time of triage or
             documented fever (defined here as ≥ 38 degrees Celsius).

          -  CDC criteria for influenza antiviral treatment is defined as: being age 65 years old
             or older, pregnant or less than two weeks postpartum, American Indian or Alaska
             native, morbid obesity (BMI ≥40), a current resident of nursing home or other
             chronic-care facility, having chronic pulmonary disease, cardiovascular disease
             (except hypertension alone), renal disease, hepatic disease, hematologic disease,
             metabolic disorders, neurologic and neurodevelopment conditions, immunosuppression
             (including that caused by medications or by HIV infection), being admitted to
             inpatient or an observation unit, or having a clinical diagnosis of pneumonia (by the
             ED physician).

        Exclusion Criteria:

          1. Does not speak and understand English (or English or Spanish)

          2. Unable or unwilling to provide informed consent

          3. Previously enrolled in the study during the current influenza season

          4. Unable to take oral medication

          5. Unable to comply with all planned study procedures including availability for
             follow-up and willingness to complete study diary and self-assessment

          6. Use of neuraminidase inhibitors within the past seven days

          7. Known allergic reaction to neuraminidase inhibitors

          8. Pregnant or breastfeeding

          9. End-stage renal disease, defined as 9a. Currently undergoing dialysis (either hemo or
             peritoneal); or 9b. Creatinine clearance (CrCl) of <10 mL/min.

         10. End-stage liver disease, as determined by the treating ED provider

         11. Glucose-6-phosphate dehydrogenase (G6PD) deficiency by patient report

         12. Immunodeficiency, defined as:

        12a. Solid organ transplant patients receiving immunosuppression; 12b. Hematopoietic stem
        cell transplant patients within 12 months of transplant or with ongoing immunosuppression;
        12c. Oncology patients who have had chemotherapy within the past 30 days; 12d. Current
        treatment with steroids equivalent to 10 mg of prednisone or more per day for greater than
        two weeks; 12e. Rheumatologic patients receiving immunosuppressive therapy; or 12f. HIV
        patients who meet one of the following criteria: 12fi. Have a cluster of differentiation 4
        (CD4) cell count of <200 cells/mm3 within the past 3 months ; 12fii. Not actively receiving
        highly active antiretroviral therapy (HAART); or 12fiii. Have an absolute lymphocyte count
        <1.0 x 103 cells/μL conducted at the current ED visit