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

This study has been terminated.
(Insufficient recruitment)
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Trial Management Group Inc.
ClinicalTrials.gov Identifier:
NCT01456234
First received: October 18, 2011
Last updated: August 7, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Influenza
Drug: Oseltamivir
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Trial Management Group Inc.:

Primary Outcome Measures:
  • Time from symptom onset to Oseltamivir access [ Time Frame: Confirmed at Visit 1, Day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Positive Predictive Value (PPV) of Influenza Clinical Diagnosis [ Time Frame: Confirmed at Visit 1, Day 1 ] [ Designated as safety issue: No ]
  • Oseltamivir Resistance [ Time Frame: Confirmed at Visit 1, Day 1 and Visit 2, Day 5 ] [ Designated as safety issue: No ]
  • Influenza Signs and Symptoms [ Time Frame: Collected from Day 1 to Day 5 ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: Collected over 21 days ] [ Designated as safety issue: Yes ]

Enrollment: 48
Study Start Date: November 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Patients with Oseltamivir Prescription
Patients arriving at the pharmacy with a prescription for Oseltamivir
Drug: Oseltamivir
Oseltamivir 75 mg BID
Other Name: 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 Name: Tamiflu

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01456234

Locations
Canada, Newfoundland and Labrador
Paradise Medical Clinic
St. John's, Newfoundland and Labrador, Canada
Canada, Ontario
Aviva Medical Clinical Trials Group
Burlington, Ontario, Canada
Co-Medica Research Network
Courtice, Ontario, Canada
Dr. Sameh Fikry Medicine Professional Corporation
Kitchener, Ontario, Canada
Springbank Medical Centre
London, Ontario, Canada
Schacter Medicine Professional Corporation
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, M9V 4B4
Canada, Quebec
Source Unique Research
Dollard des Ormeaux, Quebec, Canada
Omnispec Clinical Research Inc.
Mirabel, Quebec, Canada
Metropolitan Clinical Research Centre
Montreal, Quebec, Canada
Canada
ALPHA Recherche Clinique
Quebec, Canada
Sponsors and Collaborators
Trial Management Group Inc.
Hoffmann-La Roche
Investigators
Principal Investigator: Anil K Gupta, MD Private Practice
  More Information

No publications provided

Responsible Party: Trial Management Group Inc.
ClinicalTrials.gov Identifier: NCT01456234     History of Changes
Other Study ID Numbers: CAI-002-11
Study First Received: October 18, 2011
Last Updated: August 7, 2013
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Oseltamivir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014