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

Influenza Clinical Trial

— Access  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01456234
• Other study ID #: CAI-002-11
• Status: Terminated
• Phase: Phase 4
• First received: October 18, 2011
• Last updated: August 7, 2013
• Start date: November 2011
• Est. completion date: May 2013

Study information

• Verified date: August 2013
• Source: Trial Management Group Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 48
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Influenza

Intervention

Drug:
• Oseltamivir
Oseltamivir 75 mg BID

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Trial Management Group Inc.	Hoffmann-La Roche

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from symptom onset to Oseltamivir access		Confirmed at Visit 1, Day 1	No
Secondary	Positive Predictive Value (PPV) of Influenza Clinical Diagnosis		Confirmed at Visit 1, Day 1	No
Secondary	Oseltamivir Resistance		Confirmed at Visit 1, Day 1 and Visit 2, Day 5	No
Secondary	Influenza Signs and Symptoms		Collected from Day 1 to Day 5	No
Secondary	Adverse Events		Collected over 21 days	Yes