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| Name | Class |
|---|---|
| University of Calgary | OTHER |
| University of Alberta | OTHER |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oseltamivir | Experimental | 75 mg oseltamivir orally twice daily for 5 days within 72 hours of symptom onset |
|
| Placebo | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oseltamivir | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Non-elective Hospitalizations (number of hospitalizations) | 28 days | |
| Length of non-elective hospitalization (days) | 28 days |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Loeb, MD | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foothills Medical Centre Emergency Department | Calgary | Alberta | T2N 4W4 | Canada |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D053139 | Oseltamivir |
| D002119 | Calcium Carbonate |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 |
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|
|
| Placebo | Other | 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. |
|
|
| 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 |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D008903 | Minerals |