Time to Oseltamivir Access When Prescribed by Pharmacists Versus Physicians (ACCESS)
Information source: Trial Management Group Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Influenza
Intervention: Oseltamivir (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Trial Management Group Inc. Official(s) and/or principal investigator(s): Anil K Gupta, MD, Principal Investigator, Affiliation: Private Practice
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.
Clinical Details
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
Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Primary outcome: Time from symptom onset to Oseltamivir access
Secondary outcome: Positive Predictive Value (PPV) of Influenza Clinical DiagnosisOseltamivir Resistance Influenza Signs and Symptoms Adverse Events
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Exclusion Criteria Group 2
1. Subjects who have already started treatment with an antiviral medication for their
current influenza symptoms
2. Subjects for whom the oseltamivir prescription is not filled for any reason
3. 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)
4. Staff in the pharmacy or the primary care clinic who are involved in the study, and
their family members
Locations and Contacts
ALPHA Recherche Clinique, Quebec, Canada
Paradise Medical Clinic, St. John's, Newfoundland and Labrador, Canada
Aviva Medical Clinical Trials Group, 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
Additional Information
Starting date: November 2011
Last updated: August 7, 2013
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