InfluenzaPhase 4FOCUSNCT01249833
Effect of Oseltamivir on Cognitive Function in Subjects With Influenza
A Phase 4 study testing Oseltamivir in people with Influenza, run by Trial Management Group Inc. at 16 sites in Canada.
Trial summary
This study has been designed to determine if subjects treated with oseltamivir in addition to standard of care treatment for influenza demonstrate a greater improvement in attention / working memory / processing speed / mood as compared to subjects receiving standard of care alone. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- 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
- 122 participants
- Where
- 16 sitesCanada
- Study dates
- Nov 2010to Apr 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult men and women, 18 - 65 years of age (inclusive)
- Indicative symptoms/signs of uncomplicated acute illness due to influenza infection (A or B strains) that started within a maximum of 2 days prior to Visit 1 as per the Tamiflu® Canadian product label. Signs and symptoms may include the following:
- Fever
- Respiratory symptoms (cough, coryza, sore throat, rhinitis)
- Constitutional symptoms (headache, malaise, myalgia, sweats and/or chills, fatigue)
- Positive rapid antigen test for influenza (A or B strains) at Visit 1
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- Negative urine pregnancy test at Visit 1 for women of childbearing potential; women of childbearing potential who are sexually active must agree to use a suitable form of contraception during the study. Acceptable birth control measures include: hysterectomy, birth control pills, tubal ligation, intrauterine device, hormonal injections and implants, double barrier methods (such as a condom with a diaphragm or a condom with spermicide), and abstinence. Oral contraceptives must be in stable use for 2 or more cycles prior to screening. Intrauterine device (IUD) must be in use at least 30 days prior to study drug administration. Barrier methods must be in use at least 14 days prior to study drug administration.
- Subjects must:
- have daily access to a computer at home with: internet access (preferably high-speed for optimal performance but dial-up can be used as well); Microsoft operating system; Internet Explorer browser capability and an e-mail account. A Macintosh (Mac) computer cannot be used.
- be capable of and willing to complete the required online assessments in English according to the protocol schedule
- be willing to abstain from the use of an antiviral medication if they are randomised to the standard of care treatment arm
- have provided written informed consent prior to the initiation of any study procedures
Who cannot join
- More than 2 days since the onset of influenza symptoms
- Subjects who, in the Investigator's judgment, require treatment with an antiviral medication as per the Canadian "Clinical Recommendations for Patients Presenting with Respiratory Symptoms During the 2009 - 2010 Influenza Season" (see Appendix D)
- Clinical suspicion of infection with a respiratory virus other than influenza
- Any medical condition that is sufficiently severe or unstable such that the subject is considered to be at imminent risk of requiring hospitalisation
- History of conditions that may potentially affect cognitive function during the study, such as underlying neurologic conditions, depression or depressive disorders (unless the condition and treatment have been stable for 3 months), seasonal affective disorder (SAD), or any other cognitive impairment or dementia
- Intermittent use of sedative-hypnotics; subjects who have been taking a fixed dose of a sedative-hypnotic every day for a period of at least 30 days may be included provided that they continue the same regimen throughout the study.
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- Intermittent or chronic use of psychiatric medications (with the exception of antidepressants that have been stable for 3 months) or anti-epileptic drugs
- Nursing home residents
- Known allergy to oseltamivir phosphate or any of the inactive ingredients of Tamiflu®
- Women who are pregnant, or planning to become pregnant, or who are lactating
- Current alcohol or drug abuse or substance dependence
- Participation in another clinical trial with an investigational drug within the last 30 days
- Patients vaccinated for influenza within 6 months of study enrollment
- In the Investigator's judgment, the subject will not be able to adhere to the protocol requirements or is not suitable for study participation for any reason
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Canada16 sites
Moran Medical Centre
Collingwood, Ontario
Dr. Kanani
Etobicoke, Ontario
Dr. Herman
London, Ontario
Milestone Research
London, Ontario
SKDS Research Inc
Newmarket, Ontario
Family First Medical Centre
Orléans, Ontario
Steeple Hill Medical Centre
Pickering, Ontario, L1V 2A6
Regina Medical Centre
Regina, Saskatchewan, S4P 3X1
Dr. Martyn Chilvers - London Road Diagnostic Clinic and Medical Centre
Sarnia, Ontario
Dr. Michael O'Mahony - London Road Diagnostic Clinic and Medical Centre
Sarnia, Ontario
Topsail Road Medical Clinic
St. John's, Newfoundland and Labrador
DCTM Clinical Trials Group Ltd.
Strathroy, Ontario
Dr. Gupta
Toronto, Ontario
Dr. Collette
Vancouver, British Columbia
Dr. Lai
Vancouver, British Columbia
Devonshire Clinical Research Inc.
Woodstock, Ontario
About this study
Official title: Randomised, Open-label, Multi-Centre, Phase IV Study Assessing the Effect of Oseltamivir Treatment on Cognitive Function in Subjects With Confirmed Influenza Virus Infection
This study has been designed to determine if subjects treated with oseltamivir in addition to standard of care treatment for influenza demonstrate a greater improvement in attention / working memory / processing speed / mood as compared to subjects receiving standard of care alone. The cognitive tests employed are objective measures developed and administered online by HeadMinder Inc.
Read the detailed description
Primary Objective:
To determine if subjects treated with oseltamivir in addition to standard of care treatment for influenza demonstrate a greater improvement in attention as compared to subjects receiving standard of care alone.
Secondary Objectives:
To determine if subjects treated with oseltamivir in addition to standard of care treatment for influenza demonstrate a greater improvement in working memory and processing speed as compared to subjects receiving standard of care alone.
Supportive Objectives:
- To determine if subjects treated with oseltamivir in addition to standard of care treatment for influenza demonstrate a greater improvement in self-rated alertness as compared to subjects receiving standard of care alone.
- To determine if subjects treated with oseltamivir in addition to standard of care treatment for influenza demonstrate a greater improvement in self-rated calmness and contentment as compared to subjects receiving standard of care alone.
- To determine if there is a correlation between the rate of improvement in symptom scores and the rate of change in attention and working memory.
- Conditions
- Influenza
- Being tested
- Oseltamivir
- Keywords
- Influenza, Cognition, Attention, Simple Reaction Time, Alertness, Calmness, Contentment, Mood
- 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 75mg BID for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Oseltamivir | Active comparator | Added to standard of care for influenza Receives: Drug: Oseltamivir |
| Standard of care alone | No intervention | Standard of care for influenza |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Attention Assessment
Attention assessed using simple reaction time measured in milliseconds. Simple reaction time calculated as the mean of the following 2 sub-tests:
- Reaction Time Subtest
- Cued Reaction Time Subtest
The lower the value, the better the attention.
Measured: Change from baseline at Day 4
Secondary outcomes (2)
Change in Working Memory Assessment
Working memory assessed with the Dot Memory Test.
The higher the value, the better the working memory.
Measured: Change from baseline at Day 4
Change in Processing Speed Assessment
Processing speed assessed with the animal number decoding subtest
The lower the value, the better the processing speed
Measured: Change from baseline at Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trial Management Group Inc.
- Sponsor type
- Research network
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- Dr. O'Mahony, M.D., Principal investigator, London Road Diagnostic Clinic and Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01249833
- Sponsor's protocol ID
- CAI-001-10
- Acronym
- FOCUS
- Status last verified
- Jan 2017
- First submitted
- 26 Nov 2010
- Last updated
- 9 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Open-label, Multi-Centre, Phase IV Study Assessing the Effect of Oseltamivir Treatment on Cognitive Function in Subjects With Confirmed Influenza Virus Infection
- ClinicalTrials.gov ID
- NCT01249833
- Acronym / sponsor ID
- FOCUS / CAI-001-10
- Conditions
- Influenza
- Keywords
- Influenza, Cognition, Attention, Simple Reaction Time, Alertness, Calmness, Contentment, Mood
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Trial Management Group Inc.Research network
- Collaborators
- Hoffmann-La Roche
- Study start
- Nov 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 30 Nov 2010 (estimated)
- Results
- Posted 9 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study has been designed to determine if subjects treated with oseltamivir in addition to standard of care treatment for influenza demonstrate a greater improvement in attention / working memory / processing speed / mood as compared to subjects receiving standard of care alone. The cognitive tests employed are objective measures developed and administered online by HeadMinder Inc.
Detailed description
Primary Objective:
To determine if subjects treated with oseltamivir in addition to standard of care treatment for influenza demonstrate a greater improvement in attention as compared to subjects receiving standard of care alone.
Secondary Objectives:
To determine if subjects treated with oseltamivir in addition to standard of care treatment for influenza demonstrate a greater improvement in working memory and processing speed as compared to subjects receiving standard of care alone.
Supportive Objectives:
- To determine if subjects treated with oseltamivir in addition to standard of care treatment for influenza demonstrate a greater improvement in self-rated alertness as compared to subjects receiving standard of care alone.
- To determine if subjects treated with oseltamivir in addition to standard of care treatment for influenza demonstrate a greater improvement in self-rated calmness and contentment as compared to subjects receiving standard of care alone.
- To determine if there is a correlation between the rate of improvement in symptom scores and the rate of change in attention and working memory.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oseltamivir | Active comparator | Drug: OseltamivirAdded to standard of care for influenza |
| Standard of care alone | No intervention | –Standard of care for influenza |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Adult men and women, 18 - 65 years of age (inclusive)
- Indicative symptoms/signs of uncomplicated acute illness due to influenza infection (A or B strains) that started within a maximum of 2 days prior to Visit 1 as per the Tamiflu® Canadian product label. Signs and symptoms may include the following:
- Positive rapid antigen test for influenza (A or B strains) at Visit 1
- Negative urine pregnancy test at Visit 1 for women of childbearing potential; women of childbearing potential who are sexually active must agree to use a suitable form of contraception during the study. Acceptable birth control measures include: hysterectomy, birth control pills, tubal ligation, intrauterine device, hormonal injections and implants, double barrier methods (such as a condom with a diaphragm or a condom with spermicide), and abstinence. Oral contraceptives must be in stable use for 2 or more cycles prior to screening. Intrauterine device (IUD) must be in use at least 30 days prior to study drug administration. Barrier methods must be in use at least 14 days prior to study drug administration.
- Subjects must:
Key exclusion criteria (14 listed)
- More than 2 days since the onset of influenza symptoms
- Subjects who, in the Investigator's judgment, require treatment with an antiviral medication as per the Canadian "Clinical Recommendations for Patients Presenting with Respiratory Symptoms During the 2009 - 2010 Influenza Season" (see Appendix D)
- Clinical suspicion of infection with a respiratory virus other than influenza
- Any medical condition that is sufficiently severe or unstable such that the subject is considered to be at imminent risk of requiring hospitalisation
- History of conditions that may potentially affect cognitive function during the study, such as underlying neurologic conditions, depression or depressive disorders (unless the condition and treatment have been stable for 3 months), seasonal affective disorder (SAD), or any other cognitive impairment or dementia
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 75mg BID for 5 days | Drug | Oseltamivir |
Primary outcome
Change in Attention Assessment
Time frame: Change from baseline at Day 4
Attention assessed using simple reaction time measured in milliseconds. Simple reaction time calculated as the mean of the following 2 sub-tests: * Reaction Time Subtest * Cued Reaction Time Subtest The lower the value, the better the attention.
2 secondary outcomes
Change in Working Memory Assessment
Time frame: Change from baseline at Day 4
Change in Processing Speed Assessment
Time frame: Change from baseline at Day 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Dr. O'Mahony, M.D. principal investigator
London Road Diagnostic Clinic and Medical Centre
16 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 16 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 12 inclusion and 14 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: finished, as of the sponsor's last update on 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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?
Yes. Results are posted in the registry (first posted 9 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Attention Assessment (time frame: Change from baseline at Day 4). 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 Mar 2017.