Clinical trial NCT02561169: A Trial of Oseltamivir in High-Risk Patients Presenting to the Emergency Department With Influenza
Official title: A Randomized Controlled Trial of Oseltamivir in High-Risk Patients Presenting to the Emergency Department With Influenza
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Influenza
Keywords: antiviral
oseltamivir
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: University of Calgary
name: University of Alberta
First posted: 2015-09-25
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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%
* Confusion
* Inability to eat or drink
* Radiographic evidence of pneumonia

Primary outcomes:
measure: Non-elective Hospitalizations (number of hospitalizations)
timeFrame: 28 days
measure: Length of non-elective hospitalization (days)
timeFrame: 28 days
Secondary outcomes:
measure: Lower respiratory tract infection (LRTI), (number of LRTIs)
timeFrame: 28 days
measure: Pneumonia (number of episodes of pneumonia)
timeFrame: 28 days
measure: Acute Sinusitis (number of episodes of acute sinusitis)
timeFrame: 28 Days
measure: New antimicrobial prescription (number of antimicrobial prescriptions)
timeFrame: 28 Days
measure: Medical visits for acute respiratory illness (number of medical visits)
timeFrame: 28 Days
measure: Death
timeFrame: 3 months
measure: Adverse Events (number of adverse events)
timeFrame: 5 days
measure: Admission to intensive or critical care unit (number of admissions)
timeFrame: 28 days
measure: Duration of stay in intensive or critical care unit (days)
timeFrame: 28 days
measure: Need for mechanical ventilation (number of mechanical ventilation)
timeFrame: 28 days
measure: Duration of mechanical ventilation (days)
timeFrame: 28 days
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Centre Emergency Department
state: Alberta
Study officials:
affiliation: McMaster University
name: Mark Loeb, MD
role: PRINCIPAL_INVESTIGATOR
References: