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

Sponsor
Trial Management Group Inc. (Other)
Overall Status
Terminated
CT.gov ID
NCT01456234
Collaborator
Hoffmann-La Roche (Industry)
48
Enrollment
15
Locations
2
Arms
18
Duration (Months)
3.2
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
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 Start Date :
Nov 1, 2011
Actual Primary Completion Date :
May 1, 2013
Actual Study Completion Date :
May 1, 2013

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Time from symptom onset to Oseltamivir access [Confirmed at Visit 1, Day 1]

    Secondary Outcome Measures

    1. Positive Predictive Value (PPV) of Influenza Clinical Diagnosis [Confirmed at Visit 1, Day 1]

    2. Oseltamivir Resistance [Confirmed at Visit 1, Day 1 and Visit 2, Day 5]

    3. Influenza Signs and Symptoms [Collected from Day 1 to Day 5]

    4. Adverse Events [Collected over 21 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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)

    1. Suitable for oseltamivir treatment at a dose of 75 mg BID (see Appendix B: Algorithm for Determining Suitability of Pharmacist Prescribing of Oseltamivir)

    2. Willingness to undergo 2 nasal swab procedures

    3. Willingness to pay for (if not covered by insurance) and receive treatment with oseltamivir

    4. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Paradise Medical Clinic St. John's Newfoundland and Labrador Canada
    2 Aviva Medical Clinical Trials Group Burlington Ontario Canada
    3 Co-Medica Research Network Courtice Ontario Canada
    4 Dr. Sameh Fikry Medicine Professional Corporation Kitchener Ontario Canada
    5 Schacter Medicine Professional Corporation London Ontario Canada
    6 Springbank Medical Centre London Ontario Canada
    7 Taunton Health Centre Oshawa Ontario Canada
    8 Steeple Hill Medical Centre Pickering Ontario Canada
    9 London Road Diagnostic Clinic and Medical Centre Sarnia Ontario Canada
    10 DCTM Clinical Trials Group Ltd. Strathroy Ontario Canada
    11 Dr. Anil Gupta Toronto Ontario Canada M9V 4B4
    12 Source Unique Research Dollard des Ormeaux Quebec Canada
    13 Omnispec Clinical Research Inc. Mirabel Quebec Canada
    14 Metropolitan Clinical Research Centre Montreal Quebec Canada
    15 ALPHA Recherche Clinique Quebec Canada

    Sponsors and Collaborators

    • Trial Management Group Inc.
    • Hoffmann-La Roche

    Investigators

    • Principal Investigator: Anil K Gupta, MD, Private Practice

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Trial Management Group Inc.
    ClinicalTrials.gov Identifier:
    NCT01456234
    Other Study ID Numbers:
    • CAI-002-11
    First Posted:
    Oct 20, 2011
    Last Update Posted:
    Aug 9, 2013
    Last Verified:
    Aug 1, 2013
    Additional relevant MeSH terms:
    Oseltamivir

    Study Results

    No Results Posted as of Aug 9, 2013