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

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.

Study Overview

• Status: Terminated
• Conditions: Influenza
• Intervention / Treatment: Drug: Oseltamivir

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada
    • ALPHA Recherche Clinique
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada
      • Paradise Medical Clinic
  • Ontario
    • Burlington, Ontario, Canada
      • Aviva Medical Clinical Trials Group
    • Courtice, Ontario, Canada
      • Co-Medica Research Network
    • Kitchener, Ontario, Canada
      • Dr. Sameh Fikry Medicine Professional Corporation
    • London, Ontario, Canada
      • Schacter Medicine Professional Corporation
    • London, Ontario, Canada
      • Springbank Medical Centre
    • Oshawa, Ontario, Canada
      • Taunton Health Centre
    • Pickering, Ontario, Canada
      • Steeple Hill Medical Centre
    • Sarnia, Ontario, Canada
      • London Road Diagnostic Clinic and Medical Centre
    • Strathroy, Ontario, Canada
      • DCTM CLinical Trials Group Ltd.
    • Toronto, Ontario, Canada, M9V 4B4
      • Dr. Anil Gupta
  • Quebec
    • Dollard des Ormeaux, Quebec, Canada
      • Source Unique Research
    • Mirabel, Quebec, Canada
      • Omnispec clinical research inc.
    • Montreal, Quebec, Canada
      • Metropolitan Clinical Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Patients with Oseltamivir Prescription; Patients arriving at the pharmacy with a prescription for Oseltamivir	Drug: Oseltamivir; Oseltamivir 75 mg BID; Other Names: 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 Names: Tamiflu

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time from symptom onset to Oseltamivir access	Confirmed at Visit 1, Day 1

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Trial Management Group Inc.
• Collaborators: Hoffmann-La Roche
• Investigators: Principal Investigator: Anil K Gupta, MD, Private Practice

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: October 18, 2011
• First Submitted That Met QC Criteria: October 19, 2011
• First Posted (Estimate): October 20, 2011

Study Record Updates

• Last Update Posted (Estimate): August 9, 2013
• Last Update Submitted That Met QC Criteria: August 7, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Oseltamivir
• Other Study ID Numbers: CAI-002-11

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No