InfluenzaPhase 4NCT02561169
A Trial of Oseltamivir in High-Risk Patients Presenting to the Emergency Department With Influenza
A Phase 4 study testing Oseltamivir in people with Influenza, run by McMaster University at 1 site in Canada.
Trial summary
A multi-centre, randomized, placebo controlled, trial. Participants will be patients either ≥65 years or with one or more high risk conditions presenting to one of four academic emergency departments in Edmonton or Calgary with influenza-like illness. 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2015to Mar 2016
- 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
- Outpatient at the University of Alberta Hospital, the Northeast Community Centre, Foothills Medical Centre, Rockyview General Hospital emergency departments
- ≥ 18 years of age
- ≥ 65 years of age OR chronic cardiac or pulmonary disorders (including bronchopulmonary dysplasia, cystic fibrosis, and asthma) , diabetes mellitus and other metabolic diseases, cancer, immunodeficiency, immunosuppression (due to underlying disease and/or therapy), renal disease, anemia, and hemoglobinopathy, any condition that can compromise respiratory function or the handling of respiratory secretions or that can increase the risk of aspiration
- Acute respiratory infection (ARI) exhibiting 2 or more symptoms, onset within last 72 hours
- Laboratory confirmation of influenza infection, onset within last 72 hours
Who cannot join
- Contraindication to oseltamivir (i.e., previous anaphylaxis)
- Resident of a nursing home
- Canadian Triage and Acuity Scale (CTAS) 1
- Blood pressure < 90 mmHg
- Respiratory rate >30 breaths per minute
- PaO2 less <88%
Show all 9Show fewer
- Confusion
- Inability to eat or drink
- Radiographic evidence of pneumonia
Trial locations and contacts
1 site in 1 country.
Canada1 site
Foothills Medical Centre Emergency Department
Calgary, Alberta, T2N 4W4
About this study
Official title: A Randomized Controlled Trial of Oseltamivir in High-Risk Patients Presenting to the Emergency Department With Influenza
A multi-centre, randomized, placebo controlled, trial. Participants will be patients either ≥65 years or with one or more high risk conditions presenting to one of four academic emergency departments in Edmonton or Calgary with influenza-like illness. The investigators will test for influenza using a point-of-care rapid test and if positive for influenza participants will be randomized to oseltamivir or placebo and followed prospectively. The primary outcome will be hospitalization.
- Conditions
- Influenza
- Being tested
- Oseltamivir, Placebo
- Keywords
- antiviral, 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
Those randomized to the intervention will receive oseltamivir 75 mg orally twice daily for 5 days within 72 hours of symptom onset. For patients with a known creatinine clearance < 10 ml/min, the recommended dose of 75mg orally daily for 5 days of either intervention or placebo will be administered.
PlaceboOther
Also called Calcium Carbonate
Those randomized to the control arm will receive 75mg placebo calcium carbonate pills taken twice daily for five days within 72 hours of symptom onset and will be identical in appearance to oseltamivir. For patients with a known creatinine clearance < 10 ml/min, the recommended dose of 75mg orally daily for 5 days of either intervention or placebo will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Oseltamivir | Experimental | 75 mg oseltamivir orally twice daily for 5 days within 72 hours of symptom onset Receives: Drug: Oseltamivir |
| Placebo | Placebo comparator | 75mg placebo calcium carbonate pills taken twice daily for five days within 72 hours of symptom onset and will be identical in appearance to oseltamivir Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-elective Hospitalizations (number of hospitalizations)
Measured: 28 days
Length of non-elective hospitalization (days)
Measured: 28 days
Secondary outcomes (11)
Lower respiratory tract infection (LRTI), (number of LRTIs)
Measured: 28 days
Pneumonia (number of episodes of pneumonia)
Measured: 28 days
Acute Sinusitis (number of episodes of acute sinusitis)
Measured: 28 Days
New antimicrobial prescription (number of antimicrobial prescriptions)
Measured: 28 Days
Medical visits for acute respiratory illness (number of medical visits)
Measured: 28 Days
Death
Measured: 3 months
Adverse Events (number of adverse events)
Measured: 5 days
Admission to intensive or critical care unit (number of admissions)
Measured: 28 days
Duration of stay in intensive or critical care unit (days)
Measured: 28 days
Need for mechanical ventilation (number of mechanical ventilation)
Measured: 28 days
Duration of mechanical ventilation (days)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2015 (estimated)
- Study startDec 2015
- Primary completionMar 2016
- Study completionMar 2016
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.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Calgary, University of Alberta
- Responsible party
- Sponsor
- Investigators
- Mark Loeb, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02561169
- Sponsor's protocol ID
- Oseltamivir - 2015
- Status last verified
- Aug 2017
- First submitted
- 22 Sep 2015
- Last updated
- 4 Aug 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Oseltamivir in High-Risk Patients Presenting to the Emergency Department With Influenza
- ClinicalTrials.gov ID
- NCT02561169
- Acronym / sponsor ID
- Oseltamivir - 2015
- Conditions
- Influenza
- Keywords
- antiviral, oseltamivir
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 1 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- University of Calgary, University of Alberta
- Study start
- Dec 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 25 Sep 2015 (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.
A multi-centre, randomized, placebo controlled, trial. Participants will be patients either ≥65 years or with one or more high risk conditions presenting to one of four academic emergency departments in Edmonton or Calgary with influenza-like illness. The investigators will test for influenza using a point-of-care rapid test and if positive for influenza participants will be randomized to oseltamivir or placebo and followed prospectively. The primary outcome will be hospitalization.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oseltamivir | Experimental | Drug: Oseltamivir75 mg oseltamivir orally twice daily for 5 days within 72 hours of symptom onset |
| Placebo | Placebo comparator | Other: Placebo75mg placebo calcium carbonate pills taken twice daily for five days within 72 hours of symptom onset and will be identical in appearance to oseltamivir |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Outpatient at the University of Alberta Hospital, the Northeast Community Centre, Foothills Medical Centre, Rockyview General Hospital emergency departments
- ≥ 18 years of age
- ≥ 65 years of age OR chronic cardiac or pulmonary disorders (including bronchopulmonary dysplasia, cystic fibrosis, and asthma) , diabetes mellitus and other metabolic diseases, cancer, immunodeficiency, immunosuppression (due to underlying disease and/or therapy), renal disease, anemia, and hemoglobinopathy, any condition that can compromise respiratory function or the handling of respiratory secretions or that can increase the risk of aspiration
- Acute respiratory infection (ARI) exhibiting 2 or more symptoms, onset within last 72 hours
- Laboratory confirmation of influenza infection, onset within last 72 hours
Key exclusion criteria (9 listed)
- Contraindication to oseltamivir (i.e., previous anaphylaxis)
- Resident of a nursing home
- Canadian Triage and Acuity Scale (CTAS) 1
- Blood pressure < 90 mmHg
- Respiratory rate >30 breaths per minute
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: TamifluThose randomized to the intervention will receive oseltamivir 75 mg orally twice daily for 5 days within 72 hours of symptom onset. For patients with a known creatinine clearance < 10 ml/min, the recommended dose of 75mg orally daily for 5 days of either intervention or placebo will be administered. | Drug | Oseltamivir |
| PlaceboAlso: Calcium CarbonateThose randomized to the control arm will receive 75mg placebo calcium carbonate pills taken twice daily for five days within 72 hours of symptom onset and will be identical in appearance to oseltamivir. For patients with a known creatinine clearance < 10 ml/min, the recommended dose of 75mg orally daily for 5 days of either intervention or placebo will be administered. | Other | Placebo |
Primary outcome
Non-elective Hospitalizations (number of hospitalizations)
Time frame: 28 days
Length of non-elective hospitalization (days)
Time frame: 28 days
11 secondary outcomes
Lower respiratory tract infection (LRTI), (number of LRTIs)
Time frame: 28 days
Pneumonia (number of episodes of pneumonia)
Time frame: 28 days
Acute Sinusitis (number of episodes of acute sinusitis)
Time frame: 28 Days
New antimicrobial prescription (number of antimicrobial prescriptions)
Time frame: 28 Days
Medical visits for acute respiratory illness (number of medical visits)
Time frame: 28 Days
Death
Time frame: 3 months
Adverse Events (number of adverse events)
Time frame: 5 days
Admission to intensive or critical care unit (number of admissions)
Time frame: 28 days
Duration of stay in intensive or critical care unit (days)
Time frame: 28 days
Need for mechanical ventilation (number of mechanical ventilation)
Time frame: 28 days
Duration of mechanical ventilation (days)
Time frame: 28 days
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2017.
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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.
Mark Loeb, MD principal investigator
McMaster University
1 site 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 McMaster University at 1 site 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 5 inclusion and 9 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 4 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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. 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?
Non-elective Hospitalizations (number of hospitalizations) (time frame: 28 days). The study lists 2 primary outcomes in all. 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 4 Aug 2017.