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| Name | Class |
|---|---|
| Hoffmann-La Roche | INDUSTRY |
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The main purpose of this study is to see if patients with the flu would receive oseltamivir treatment more quickly if it were prescribed by a pharmacist as compared to a physician, and to see if there is any difference in the effect of treatment on flu symptoms and overall health. Another reason for doing the study is to see how accurately pharmacists can diagnose the flu as compared to physicians. Viruses that are exposed to antiviral medications (like oseltamivir) sometimes develop a resistance to the medication. This means that the medication is no longer as effective in treating the symptoms caused by the virus. The development of viral resistance to oseltamivir will also be followed in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Oseltamivir Prescription | Active Comparator | Patients arriving at the pharmacy with a prescription for Oseltamivir |
|
| Patients with signs, symptoms of flu | Experimental | Patients arriving at the pharmacy with signs, symptoms of flu that the pharmacist diagnoses as having flu and being suitable for pharmacist prescribing of Oseltamivir according to an algorithm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oseltamivir | Drug | Oseltamivir 75 mg BID |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time from symptom onset to Oseltamivir access | Confirmed at Visit 1, Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Positive Predictive Value (PPV) of Influenza Clinical Diagnosis | Confirmed at Visit 1, Day 1 | |
| Oseltamivir Resistance | Confirmed at Visit 1, Day 1 and Visit 2, Day 5 | |
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Inclusion Criteria Group 1
Inclusion Criteria Group 2
Male and female subjects ≥ 18 years of age presenting at the pharmacy with indicative clinical symptoms/signs of uncomplicated acute illness due to influenza infection that started within a maximum of 2 days prior to the visit to the pharmacy (see Appendix A:
FACTSS Influenza Diagnostic Tool)
Suitable for oseltamivir treatment at a dose of 75 mg BID (see Appendix B: Algorithm for Determining Suitability of Pharmacist Prescribing of Oseltamivir)
Willingness to undergo 2 nasal swab procedures
Willingness to pay for (if not covered by insurance) and receive treatment with oseltamivir
Willingness to participate in the study as evidenced by a written and signed Informed Consent Form
Exclusion Criteria Group 1
Exclusion Criteria Group 2
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| Name | Affiliation | Role |
|---|---|---|
| Anil K Gupta, MD | Private Practice | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Paradise Medical Clinic | St. John's | Newfoundland and Labrador | Canada | |||
| Aviva Medical Clinical Trials Group |
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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 |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 |
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| Influenza Signs and Symptoms |
| Collected from Day 1 to Day 5 |
| Adverse Events | Collected over 21 days |
| Burlington |
| Ontario |
| Canada |
| Co-Medica Research Network | Courtice | Ontario | Canada |
| Dr. Sameh Fikry Medicine Professional Corporation | Kitchener | Ontario | Canada |
| Schacter Medicine Professional Corporation | London | Ontario | Canada |
| Springbank Medical Centre | London | Ontario | Canada |
| Taunton Health Centre | Oshawa | Ontario | Canada |
| Steeple Hill Medical Centre | Pickering | Ontario | Canada |
| London Road Diagnostic Clinic and Medical Centre | Sarnia | Ontario | Canada |
| DCTM Clinical Trials Group Ltd. | Strathroy | Ontario | Canada |
| Dr. Anil Gupta | Toronto | Ontario | M9V 4B4 | Canada |
| Source Unique Research | Dollard-des-Ormeaux | Quebec | Canada |
| Omnispec Clinical Research Inc. | Mirabel | Quebec | Canada |
| Metropolitan Clinical Research Centre | Montreal | Quebec | Canada |
| ALPHA Recherche Clinique | Québec | Quebec | Canada |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |