ED Influenza Therapeutic Pilot Study: Oseltamivir vs. Peramivir

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.

Timeline

Start

2015-11-01

Primary completion

2017-05-26

Completion

2018-05-31

Drugs

Indications