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

Study Overview
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Brief Summary
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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.

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

Conditions
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Influenza

Intervention / Treatment
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* Drug: Oseltamivir
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oseltamivir<br>75 mg oseltamivir orally twice daily for 5 days within 72 hours of symptom onset | Drug: Oseltamivir<br>* 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.<br>* Other names: Tamiflu;|
| Placebo Comparator: Placebo<br>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<br>* 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.<br>* Other names: Calcium Carbonate;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Duration of mechanical ventilation (days) |  | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antiviral, oseltamivir