InfluenzaPhase 4AccessNCT01456234
Time to Oseltamivir Access When Prescribed by Pharmacists Versus Physicians (ACCESS)
A Phase 4 study testing Oseltamivir in people with Influenza, run by Trial Management Group Inc. at 15 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Influenza
- What is being tested?
- Oseltamivir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 15 sitesCanada
- Study dates
- Nov 2011to May 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Willingness to undergo 2 nasal swab procedures
- Willingness to participate in the study as evidenced by a written and signed Informed Consent Form
- 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)
- Suitable for oseltamivir treatment at a dose of 75 mg BID (see Appendix B: Algorithm for Determining Suitability of Pharmacist Prescribing of Oseltamivir)
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- Willingness to undergo 2 nasal swab procedures
- Willingness to pay for (if not covered by insurance) and receive treatment with oseltamivir
- Willingness to participate in the study as evidenced by a written and signed Informed Consent Form
Who cannot join
- 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
- 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)
- Subjects who have received an oseltamivir prescription from a physician participating in the study
- Subjects for whom the oseltamivir prescription is not filled for any reason
- Subjects who, in the opinion of research personnel, will not comply with the study procedures
- Staff in the pharmacy or the primary care clinic who are involved in the study, and their family members
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- Subjects who have already started treatment with an antiviral medication for their current influenza symptoms
- Subjects for whom the oseltamivir prescription is not filled for any reason
- 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)
- Staff in the pharmacy or the primary care clinic who are involved in the study, and their family members
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Canada15 sites
Aviva Medical Clinical Trials Group
Burlington, Ontario
Co-Medica Research Network
Courtice, Ontario
Source Unique Research
Dollard-des-Ormeaux, Quebec
Dr. Sameh Fikry Medicine Professional Corporation
Kitchener, Ontario
Schacter Medicine Professional Corporation
London, Ontario
Springbank Medical Centre
London, Ontario
Omnispec Clinical Research Inc.
Mirabel, Quebec
Metropolitan Clinical Research Centre
Montreal, Quebec
Taunton Health Centre
Oshawa, Ontario
Steeple Hill Medical Centre
Pickering, Ontario
ALPHA Recherche Clinique
Québec, Quebec
London Road Diagnostic Clinic and Medical Centre
Sarnia, Ontario
Paradise Medical Clinic
St. John's, Newfoundland and Labrador
DCTM Clinical Trials Group Ltd.
Strathroy, Ontario
Dr. Anil Gupta
Toronto, Ontario, M9V 4B4
About this study
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
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.
- Conditions
- Influenza
- Being tested
- Oseltamivir
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OseltamivirDrug
Also called Tamiflu
Oseltamivir 75 mg BID
| Study group | Role | What they receive |
|---|---|---|
| Patients with Oseltamivir Prescription | Active comparator | Patients arriving at the pharmacy with a prescription for Oseltamivir Receives: Drug: Oseltamivir |
| Patients with signs, symptoms of flu | Experimental | 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. Receives: Drug: Oseltamivir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from symptom onset to Oseltamivir access
Measured: Confirmed at Visit 1, Day 1
Secondary outcomes (4)
Positive Predictive Value (PPV) of Influenza Clinical Diagnosis
Measured: Confirmed at Visit 1, Day 1
Oseltamivir Resistance
Measured: Confirmed at Visit 1, Day 1 and Visit 2, Day 5
Influenza Signs and Symptoms
Measured: Collected from Day 1 to Day 5
Adverse Events
Measured: Collected over 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2011 (estimated)
- Study startNov 2011
- Primary completionMay 2013
- Study completionMay 2013
Why it stopped: Insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trial Management Group Inc.
- Sponsor type
- Research network
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- Anil K Gupta, MD, Principal investigator, Private Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01456234
- Sponsor's protocol ID
- CAI-002-11
- Acronym
- Access
- Status last verified
- Aug 2013
- First submitted
- 18 Oct 2011
- Last updated
- 9 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01456234
- Acronym / sponsor ID
- Access / CAI-002-11
- Conditions
- Influenza
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Trial Management Group Inc.Research network
- Collaborators
- Hoffmann-La Roche
- Study start
- Nov 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 20 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Oseltamivir Prescription | Active comparator | Drug: OseltamivirPatients arriving at the pharmacy with a prescription for Oseltamivir |
| Patients with signs, symptoms of flu | Experimental | Drug: OseltamivirPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- Willingness to undergo 2 nasal swab procedures
- Willingness to participate in the study as evidenced by a written and signed Informed Consent Form
- 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)
Key exclusion criteria (10 listed)
- 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
- 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)
- Subjects who have received an oseltamivir prescription from a physician participating in the study
- Subjects for whom the oseltamivir prescription is not filled for any reason
- Subjects who, in the opinion of research personnel, will not comply with the study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OseltamivirAlso: TamifluOseltamivir 75 mg BID | Drug | Patients with Oseltamivir Prescription, Patients with signs, symptoms of flu |
Primary outcome
Time from symptom onset to Oseltamivir access
Time frame: Confirmed at Visit 1, Day 1
4 secondary outcomes
Positive Predictive Value (PPV) of Influenza Clinical Diagnosis
Time frame: Confirmed at Visit 1, Day 1
Oseltamivir Resistance
Time frame: Confirmed at Visit 1, Day 1 and Visit 2, Day 5
Influenza Signs and Symptoms
Time frame: Collected from Day 1 to Day 5
Adverse Events
Time frame: Collected over 21 days
Results and safety
The study was stopped early (reason given: Insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anil K Gupta, MD principal investigator
Private Practice
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oseltamivir in people with Influenza, run by Trial Management Group Inc. at 15 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Insufficient recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from symptom onset to Oseltamivir access (time frame: Confirmed at Visit 1, Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2013.