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A Trial of Oseltamivir in High-Risk Patients Presenting to the Emergency Department With Influenza

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02561169
First Posted: September 25, 2015
Last Update Posted: August 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Calgary
University of Alberta
Information provided by (Responsible Party):
McMaster University
  Purpose
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.

Condition Intervention Phase
Influenza Drug: Oseltamivir Other: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Official Title: A Randomized Controlled Trial of Oseltamivir in High-Risk Patients Presenting to the Emergency Department With Influenza

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Non-elective Hospitalizations (number of hospitalizations) [ Time Frame: 28 days ]
  • Length of non-elective hospitalization (days) [ Time Frame: 28 days ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1
Study Start Date: December 2015
Study Completion Date: March 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oseltamivir
75 mg oseltamivir orally twice daily for 5 days within 72 hours of symptom onset
Drug: Oseltamivir
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.
Other Name: Tamiflu
Placebo Comparator: Placebo
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
Other: Placebo
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.
Other Name: Calcium Carbonate

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02561169


Locations
Canada, Alberta
Foothills Medical Centre Emergency Department
Calgary, Alberta, Canada, T2N 4W4
Sponsors and Collaborators
McMaster University
University of Calgary
University of Alberta
Investigators
Principal Investigator: Mark Loeb, MD McMaster University
  More Information

Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT02561169     History of Changes
Other Study ID Numbers: Oseltamivir - 2015
First Submitted: September 22, 2015
First Posted: September 25, 2015
Last Update Posted: August 4, 2017
Last Verified: August 2017

Keywords provided by McMaster University:
antiviral
oseltamivir

Additional relevant MeSH terms:
Influenza, Human
Emergencies
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Oseltamivir
Calcium Carbonate
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antacids
Gastrointestinal Agents