Study Stopped
Insufficient recruitment
Time to Oseltamivir Access When Prescribed by Pharmacists Versus Physicians (ACCESS)
Access
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
1 other identifier
interventional
48
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Nov 2011
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 18, 2011
CompletedFirst Posted
Study publicly available on registry
October 20, 2011
CompletedStudy Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedAugust 9, 2013
August 1, 2013
1.5 years
October 18, 2011
August 7, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Time from symptom onset to Oseltamivir access
Confirmed at Visit 1, Day 1
Secondary Outcomes (4)
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
Study Arms (2)
Patients with Oseltamivir Prescription
ACTIVE COMPARATORPatients arriving at the pharmacy with a prescription for Oseltamivir
Patients with signs, symptoms of flu
EXPERIMENTALPatients 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.
Interventions
Oseltamivir 75 mg BID
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Trial Management Group Inc.lead
- Hoffmann-La Rochecollaborator
Study Sites (15)
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
ALPHA Recherche Clinique
Québec, Quebec, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anil K Gupta, MD
Private Practice
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2011
First Posted
October 20, 2011
Study Start
November 1, 2011
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
August 9, 2013
Record last verified: 2013-08