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

Information source: Trial Management Group Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Influenza

Intervention: Oseltamivir (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Trial Management Group Inc.

Official(s) and/or principal investigator(s):
Anil K Gupta, MD, Principal Investigator, Affiliation: Private Practice

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.

Clinical Details

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 design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Primary outcome: Time from symptom onset to Oseltamivir access

Secondary outcome:

Positive Predictive Value (PPV) of Influenza Clinical Diagnosis

Oseltamivir Resistance

Influenza Signs and Symptoms

Adverse Events

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

ALPHA Recherche Clinique, Quebec, Canada

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 M9V 4B4, Canada

Source Unique Research, Dollard des Ormeaux, Quebec, Canada

Omnispec Clinical Research Inc., Mirabel, Quebec, Canada

Metropolitan Clinical Research Centre, Montreal, Quebec, Canada

Additional Information

Starting date: November 2011
Last updated: August 7, 2013

Page last updated: August 23, 2015

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