A Trial of Oseltamivir in High-Risk Patients Presenting to the Emergency Department With Influenza
- Registration Number
- NCT02561169
- Lead Sponsor
- McMaster University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo 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 Oseltamivir Oseltamivir 75 mg oseltamivir orally twice daily for 5 days within 72 hours of symptom onset
- Primary Outcome Measures
Name Time Method Non-elective Hospitalizations (number of hospitalizations) 28 days Length of non-elective hospitalization (days) 28 days
- Secondary Outcome Measures
Name Time Method Duration of mechanical ventilation (days) 28 days 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 Death 3 months 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
Trial Locations
- Locations (1)
Foothills Medical Centre Emergency Department
🇨🇦Calgary, Alberta, Canada