Influenza Clinical Trial
Official title:
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.
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