Influenza
Conditions
Brief summary
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.
Interventions
DRUGOseltamivir
Oseltamivir 75 mg BID
Sponsors
Hoffmann-La Roche
Trial Management Group Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Group 1 1. Male and female subjects ≥ 18 years of age presenting at the pharmacy with a current prescription for oseltamivir (75 mg capsule BID for 5 days as per the Canadian label) for the treatment of their own current influenza symptoms 2. Willingness to undergo 2 nasal swab procedures 3. Willingness to participate in the study as evidenced by a written and signed Informed Consent Form Inclusion Criteria Group 2 1. 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) 2. Suitable for oseltamivir treatment at a dose of 75 mg BID (see Appendix B: Algorithm for Determining Suitability of Pharmacist Prescribing of Oseltamivir) 3. Willingness to undergo 2 nasal swab procedures 4. Willingness to pay for (if not covered by insurance) and receive treatment with oseltamivir 5. Willingness to participate in the study as evidenced by a written and signed Informed Consent Form
Exclusion criteria
Group 1 1. Subjects who have been prescribed any other formulation (i.e., oral suspension) or dose regimen of oseltamivir, or any other antiviral medication for the treatment of influenza 2. Individuals presenting at the pharmacy with an oseltamivir prescription who themselves do not currently have a diagnosis of influenza (e.g., individuals filling a prescription for someone else who is currently infected with influenza; individuals filling a prescription that they or someone else will use for prevention of influenza infection or for treatment of a future influenza infection) 3. Subjects who have received an oseltamivir prescription from a physician participating in the study 4. Subjects for whom the oseltamivir prescription is not filled for any reason 5. Subjects who, in the opinion of research personnel, will not comply with the study procedures 6. Staff in the pharmacy or the primary care clinic who are involved in the study, and their family members
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time from symptom onset to Oseltamivir access | Confirmed at Visit 1, Day 1 |
Secondary
| Measure | 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 |
| Influenza Signs and Symptoms | Collected from Day 1 to Day 5 |
| Adverse Events | Collected over 21 days |
Countries
Canada
Outcome results
None listed