Time to Oseltamivir Access When Prescribed by Pharmacists Versus Physicians (ACCESS)

NCT ID: NCT01456234

Last Updated: 2013-08-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2013-05-31

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.

Conditions

Influenza

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Patients with Oseltamivir Prescription

Patients arriving at the pharmacy with a prescription for Oseltamivir

Group Type: ACTIVE_COMPARATOR

Oseltamivir

Intervention Type: DRUG

Oseltamivir 75 mg BID

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.

Group Type: EXPERIMENTAL

Oseltamivir

Intervention Type: DRUG

Oseltamivir 75 mg BID

Interventions

Oseltamivir

Oseltamivir 75 mg BID

Intervention Type: DRUG

Other Intervention Names

Tamiflu

Eligibility Criteria

Inclusion Criteria

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

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

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: collaborator

Trial Management Group Inc.

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anil K Gupta, MD

Role: PRINCIPAL_INVESTIGATOR

Private Practice

Locations

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, 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

Countries

Canada

Other Identifiers

CAI-002-11

Identifier Type: -

Identifier Source: org_study_id