Overview

A Trial of Oseltamivir in High-Risk Patients Presenting to the Emergency Department With Influenza

Status:
Terminated
Trial end date:
2016-03-01
Target enrollment:
0
Participant gender:
All
Summary
A multi-centre, randomized, placebo controlled, trial. Participants will be patients either ≥65 years or with one or more high risk conditions presenting to one of four academic emergency departments in Edmonton or Calgary with influenza-like illness. The investigators will test for influenza using a point-of-care rapid test and if positive for influenza participants will be randomized to oseltamivir or placebo and followed prospectively. The primary outcome will be hospitalization.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
McMaster University
Collaborators:
University of Alberta
University of Calgary
Treatments:
Calcium Carbonate
Oseltamivir
Criteria
Inclusion Criteria:

- Outpatient at the University of Alberta Hospital, the Northeast Community Centre,
Foothills Medical Centre, Rockyview General Hospital emergency departments

- ≥ 18 years of age

- ≥ 65 years of age OR chronic cardiac or pulmonary disorders (including
bronchopulmonary dysplasia, cystic fibrosis, and asthma) , diabetes mellitus and other
metabolic diseases, cancer, immunodeficiency, immunosuppression (due to underlying
disease and/or therapy), renal disease, anemia, and hemoglobinopathy, any condition
that can compromise respiratory function or the handling of respiratory secretions or
that can increase the risk of aspiration

- Acute respiratory infection (ARI) exhibiting 2 or more symptoms, onset within last 72
hours

- Laboratory confirmation of influenza infection, onset within last 72 hours

Exclusion Criteria:

- Contraindication to oseltamivir (i.e., previous anaphylaxis)

- Resident of a nursing home

- Canadian Triage and Acuity Scale (CTAS) 1

- Blood pressure < 90 mmHg

- Respiratory rate >30 breaths per minute

- PaO2 less <88%

- Confusion

- Inability to eat or drink

- Radiographic evidence of pneumonia