Clinical trial NCT01456234: Time to Oseltamivir Access When Prescribed by Pharmacists Versus Physicians (ACCESS)
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Influenza
Lead sponsor: Trial Management Group Inc.
Sponsor class: NETWORK
Collaborators: name: Hoffmann-La Roche
First posted: 2011-10-20
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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

Primary outcomes:
measure: Time from symptom onset to Oseltamivir access
timeFrame: Confirmed at Visit 1, Day 1
Secondary outcomes:
measure: Positive Predictive Value (PPV) of Influenza Clinical Diagnosis
timeFrame: Confirmed at Visit 1, Day 1
measure: Oseltamivir Resistance
timeFrame: Confirmed at Visit 1, Day 1 and Visit 2, Day 5
measure: Influenza Signs and Symptoms
timeFrame: Collected from Day 1 to Day 5
measure: Adverse Events
timeFrame: Collected over 21 days
Other outcomes:
Locations:
city: St. John's
country: Canada
facility: Paradise Medical Clinic
state: Newfoundland and Labrador
city: Burlington
country: Canada
facility: Aviva Medical Clinical Trials Group
state: Ontario
city: Courtice
country: Canada
facility: Co-Medica Research Network
state: Ontario
city: Kitchener
country: Canada
facility: Dr. Sameh Fikry Medicine Professional Corporation
state: Ontario
city: London
country: Canada
facility: Schacter Medicine Professional Corporation
state: Ontario
city: London
country: Canada
facility: Springbank Medical Centre
state: Ontario
city: Oshawa
country: Canada
facility: Taunton Health Centre
state: Ontario
city: Pickering
country: Canada
facility: Steeple Hill Medical Centre
state: Ontario
city: Sarnia
country: Canada
facility: London Road Diagnostic Clinic and Medical Centre
state: Ontario
city: Strathroy
country: Canada
facility: DCTM Clinical Trials Group Ltd.
state: Ontario
city: Toronto
country: Canada
facility: Dr. Anil Gupta
state: Ontario
city: Dollard des Ormeaux
country: Canada
facility: Source Unique Research
state: Quebec
city: Mirabel
country: Canada
facility: Omnispec Clinical Research Inc.
state: Quebec
city: Montreal
country: Canada
facility: Metropolitan Clinical Research Centre
state: Quebec
city: Quebec
country: Canada
facility: ALPHA Recherche Clinique
Study officials:
affiliation: Private Practice
name: Anil K Gupta, MD
role: PRINCIPAL_INVESTIGATOR
References: