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The proposed pilot study will provide needed data to establish the feasibility of a conducting a large randomized controlled trial as to the effectiveness of the use of oseltamivir early in the course of influenza in outpatients with chronic pulmonary disease.
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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 | They will be assessed for eligibility at the clinics and those randomized to the intervention will receive oseltamivir 75 mg orally twice daily for 5 days within 72 hours of symptom onset. Participants randomized to the control group will receive calcium carbonate placebo pills twice daily for five 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 admission to hospital | A non-elective admission to hospital, in contrast to visits to the emergency department where admission does not take place. However, a prolonged stay in the emergency department (> 24 hours) will also be considered to be hospitalization. Events that occur beyond this time period are deemed unlikely to be directly related to influenza,except functional status which will be assessed up to three months following acute respiratory infection. Secondly, the hospitalization must also be considered to be due to acute respiratory illness. An adjudication committee (comprised of two infectious diseases physicians who also practice general internal medicine) blinded to study group allocation will review data for hospitalization. They will be asked to judge whether the hospitalization was definitely or probably related to the acute respiratory illness. Those judged to be definitely or probably related will be considered as our primary outcome. | up to 28 days following randomization |
| Measure | Description | Time Frame |
|---|---|---|
| lower respiratory tract infection | lower respiratory tract infection including exacerbation of chronic pulmonary disease | up to 28 days following randomization |
| Measure | Description | Time Frame |
|---|---|---|
| pneumonia | up to 28 days following randomization | |
| neutrophilic bronchitis | up to 28 days following randomization | |
| acute sinusitis |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark B Loeb, MD | McMaster University | Principal Investigator |
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| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae 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 |
|
|
| up to 28 days following randomization |
| antimicrobial prescriptions | up to 28 days following randomization |
| visits to medical providers | visits to emergency department without admission and non-routine visits to other physician clinics will be assessed separately | up to 28 days following randomization |
| changes in functional status | This outcome will be measured using Activities of Daily Living (ADL) score, an index of independence of activities of daily living. Will be assessed at baseline, 2 weeks, 1 month, 3 months after acute respiratory infection onset | up to 3 months from randomization |
| absenteeism from work | up to 28 days from randomization |
| additional care or support needed in the home | Need for new or additional informal caregiver support in the home, need for professional help in the home, transfer to a residential facility, need for rehabilitation for up to 3 months. | up to 3 months following randomization |
| laboratory testing using RT-PCR for influenza | up to 28 days following randomization |
| D012327 | RNA Virus Infections |
| D014777 | Virus 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 |