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

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

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.

Study Overview

• Status: Terminated
• Conditions: Influenza
• Intervention / Treatment: Drug: Oseltamivir; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4W4
      • Foothills Medical Centre Emergency Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oseltamivir; 75 mg oseltamivir orally twice daily for 5 days within 72 hours of symptom onset	Drug: Oseltamivir; Those randomized to the intervention will receive oseltamivir 75 mg orally twice daily for 5 days within 72 hours of symptom onset. For patients with a known creatinine clearance < 10 ml/min, the recommended dose of 75mg orally daily for 5 days of either intervention or placebo will be administered.; Other Names: Tamiflu
Placebo Comparator: Placebo; 75mg placebo calcium carbonate pills taken twice daily for five days within 72 hours of symptom onset and will be identical in appearance to oseltamivir	Other: Placebo; Those randomized to the control arm will receive 75mg placebo calcium carbonate pills taken twice daily for five days within 72 hours of symptom onset and will be identical in appearance to oseltamivir. For patients with a known creatinine clearance < 10 ml/min, the recommended dose of 75mg orally daily for 5 days of either intervention or placebo will be administered.; Other Names: Calcium Carbonate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Non-elective Hospitalizations (number of hospitalizations)	28 days
Length of non-elective hospitalization (days)	28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Death	3 months
Lower respiratory tract infection (LRTI), (number of LRTIs)	28 days
Pneumonia (number of episodes of pneumonia)	28 days
Acute Sinusitis (number of episodes of acute sinusitis)	28 Days
New antimicrobial prescription (number of antimicrobial prescriptions)	28 Days
Medical visits for acute respiratory illness (number of medical visits)	28 Days
Adverse Events (number of adverse events)	5 days
Admission to intensive or critical care unit (number of admissions)	28 days
Duration of stay in intensive or critical care unit (days)	28 days
Need for mechanical ventilation (number of mechanical ventilation)	28 days
Duration of mechanical ventilation (days)	28 days

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: University of Alberta; University of Calgary
• Investigators: Principal Investigator: Mark Loeb, MD, McMaster University

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: September 22, 2015
• First Submitted That Met QC Criteria: September 24, 2015
• First Posted (Estimate): September 25, 2015

Study Record Updates

• Last Update Posted (Actual): August 4, 2017
• Last Update Submitted That Met QC Criteria: August 3, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: antiviral; oseltamivir
• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Disease Attributes; Orthomyxoviridae Infections; Emergencies; Influenza, Human; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Gastrointestinal Agents; Antacids; Calcium Carbonate; Oseltamivir
• Other Study ID Numbers: Oseltamivir - 2015