Status:
TERMINATED
Time to Oseltamivir Access When Prescribed by Pharmacists Versus Physicians (ACCESS)
Lead Sponsor:
Trial Management Group Inc.
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Influenza
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- Inclusion Criteria Group 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
- Willingness to undergo 2 nasal swab procedures
- Willingness to participate in the study as evidenced by a written and signed Informed Consent Form
- 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
- 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
- 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)
- Subjects who have received an oseltamivir prescription from a physician participating in the study
- Subjects for whom the oseltamivir prescription is not filled for any reason
- Subjects who, in the opinion of research personnel, will not comply with the study procedures
- Staff in the pharmacy or the primary care clinic who are involved in the study, and their family members
- Exclusion Criteria Group 2
- Subjects who have already started treatment with an antiviral medication for their current influenza symptoms
- Subjects for whom the oseltamivir prescription is not filled for any reason
- Subjects who, in the opinion of the investigator, are not suitable for the study for clinical or other reasons (e.g., the patient requires hospitalisation or will not be able to comply with study procedures)
- Staff in the pharmacy or the primary care clinic who are involved in the study, and their family members
Exclusion
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01456234
Start Date
November 1 2011
End Date
May 1 2013
Last Update
August 9 2013
Active Locations (15)
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1
Paradise Medical Clinic
St. John's, Newfoundland and Labrador, Canada
2
Aviva Medical Clinical Trials Group
Burlington, Ontario, Canada
3
Co-Medica Research Network
Courtice, Ontario, Canada
4
Dr. Sameh Fikry Medicine Professional Corporation
Kitchener, Ontario, Canada