ED Influenza Therapeutic Pilot Study: Oseltamivir vs. Peramivir

Status:	Active, not recruiting
Conditions:	Influenza
Therapuetic Areas:	Immunology / Infectious Diseases
Healthy:	No
Age Range:	18 - 100
Updated:	12/2/2018
Start Date:	November 1, 2015
End Date:	August 21, 2019

Influenza Therapeutic Trial: A Pilot Randomized Controlled Trial for Feasibility of Enrolling Subjects for Influenza Therapeutic Trials and Administering Influenza Antivirals in the Emergency Department to High Risk Subjects

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.

Title: A Pilot Randomized Controlled Trial for Feasibility of Enrolling Subjects for
Influenza Therapeutic Trials and Administering Influenza Antivirals in the Emergency
Department to High Risk Subjects

Population: Adults presenting to the emergency department (ED) with laboratory confirmed
influenza who meet Centers for Disease Control and Prevention (CDC) criteria for antiviral
treatment

Informed consent: Written informed consent

Number of Sites: 2 - large, urban, academically-affiliated, US EDs

Study Duration: November 2015 - June 2018

Subject Participation Duration: 4 weeks

Description of Agent or Intervention: Subjects will be randomized to either oral
(oseltamivir) or intravenous (IV) (peramivir) antiviral treatment.

Description of Study Design: This is an open-label randomized controlled clinical trial in
which subjects with influenza are randomized to either oral (oseltamivir) or IV (peramivir)
antiviral treatment.

Estimated Time to Complete Enrollment: Subject enrollment will occur over two influenza
seasons (November 2015 - April 2016 and November 2016 - April 2017) or longer, at the
Principal Investigator's discretion, based on influenza prevalence.

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

We found this trial at

sites

Johns Hopkins Hospital

1800 Orleans St.
Baltimore, Maryland 21287

410-955-5000