Time to Oseltamivir Access When Prescribed by Pharmacists Versus Physicians (ACCESS)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Influenza |
Drug: Oseltamivir |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | Comparison of Time From Symptom Onset to Oseltamivir Access When Oseltamivir is Prescribed by Pharmacists vs. Physicians and the Impact on Symptoms, Oseltamivir Resistance, and Patient Safety |
- Time from symptom onset to Oseltamivir access [ Time Frame: Confirmed at Visit 1, Day 1 ] [ Designated as safety issue: No ]
- Positive Predictive Value (PPV) of Influenza Clinical Diagnosis [ Time Frame: Confirmed at Visit 1, Day 1 ] [ Designated as safety issue: No ]
- Oseltamivir Resistance [ Time Frame: Confirmed at Visit 1, Day 1 and Visit 2, Day 5 ] [ Designated as safety issue: No ]
- Influenza Signs and Symptoms [ Time Frame: Collected from Day 1 to Day 5 ] [ Designated as safety issue: No ]
- Adverse Events [ Time Frame: Collected over 21 days ] [ Designated as safety issue: Yes ]
| Enrollment: | 48 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Patients with Oseltamivir Prescription
Patients arriving at the pharmacy with a prescription for Oseltamivir
|
Drug: Oseltamivir
Oseltamivir 75 mg BID
Other Name: Tamiflu
|
|
Experimental: Patients with signs, symptoms of flu
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.
|
Drug: Oseltamivir
Oseltamivir 75 mg BID
Other Name: Tamiflu
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Canada, Newfoundland and Labrador | |
| Paradise Medical Clinic | |
| St. John's, Newfoundland and Labrador, Canada | |
| Canada, Ontario | |
| Aviva Medical Clinical Trials Group | |
| Burlington, Ontario, Canada | |
| Co-Medica Research Network | |
| Courtice, Ontario, Canada | |
| Dr. Sameh Fikry Medicine Professional Corporation | |
| Kitchener, Ontario, Canada | |
| Springbank Medical Centre | |
| London, Ontario, Canada | |
| Schacter Medicine Professional Corporation | |
| 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, Canada, M9V 4B4 | |
| Canada, Quebec | |
| Source Unique Research | |
| Dollard des Ormeaux, Quebec, Canada | |
| Omnispec Clinical Research Inc. | |
| Mirabel, Quebec, Canada | |
| Metropolitan Clinical Research Centre | |
| Montreal, Quebec, Canada | |
| Canada | |
| ALPHA Recherche Clinique | |
| Quebec, Canada | |
| Principal Investigator: | Anil K Gupta, MD | Private Practice |
More Information
No publications provided
| Responsible Party: | Trial Management Group Inc. |
| ClinicalTrials.gov Identifier: | NCT01456234 History of Changes |
| Other Study ID Numbers: | CAI-002-11 |
| Study First Received: | October 18, 2011 |
| Last Updated: | April 18, 2013 |
| Health Authority: | Canada: Health Canada |
Additional relevant MeSH terms:
|
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases Oseltamivir |
Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 22, 2013