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

Phase 4

Terminated

• Conditions: Influenza
• Interventions: Drug: Oseltamivir

• Registration Number: NCT01456234
• Lead Sponsor: Trial Management Group Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-18
• Study First Submitted QC: 2011-10-19
• Study First Posted: 2011-10-20
• Study Start: 2011-11
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-07
• Last Update Posted: 2013-08-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with Oseltamivir Prescription	Oseltamivir	Patients arriving at the pharmacy with a prescription for Oseltamivir
Patients with signs, symptoms of flu	Oseltamivir	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.

Primary Outcome Measures

Name	Time	Method
Time from symptom onset to Oseltamivir access	Confirmed at Visit 1, Day 1

Secondary Outcome Measures

Name	Time	Method
Positive Predictive Value (PPV) of Influenza Clinical Diagnosis	Confirmed at Visit 1, Day 1
Oseltamivir Resistance	Confirmed at Visit 1, Day 1 and Visit 2, Day 5
Influenza Signs and Symptoms	Collected from Day 1 to Day 5
Adverse Events	Collected over 21 days

Trial Locations

Locations (15)

Springbank Medical Centre; 🇨🇦 London, Ontario, Canada

London Road Diagnostic Clinic and Medical Centre; 🇨🇦 Sarnia, Ontario, Canada

Dr. Anil Gupta; 🇨🇦 Toronto, Ontario, Canada

DCTM Clinical Trials Group Ltd.; 🇨🇦 Strathroy, Ontario, Canada

Source Unique Research; 🇨🇦 Dollard des Ormeaux, Quebec, Canada

ALPHA Recherche Clinique; 🇨🇦 Quebec, Canada

Metropolitan Clinical Research Centre; 🇨🇦 Montreal, Quebec, Canada

Paradise Medical Clinic; 🇨🇦 St. John's, Newfoundland and Labrador, Canada

Dr. Sameh Fikry Medicine Professional Corporation; 🇨🇦 Kitchener, Ontario, Canada

Co-Medica Research Network; 🇨🇦 Courtice, Ontario, Canada

Aviva Medical Clinical Trials Group; 🇨🇦 Burlington, Ontario, Canada

Schacter Medicine Professional Corporation; 🇨🇦 London, Ontario, Canada

Steeple Hill Medical Centre; 🇨🇦 Pickering, Ontario, Canada

Taunton Health Centre; 🇨🇦 Oshawa, Ontario, Canada

Omnispec Clinical Research Inc.; 🇨🇦 Mirabel, Quebec, Canada