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

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified September 2015 by McMaster University
Sponsor:
Collaborators:
University of Calgary
University of Alberta
Information provided by (Responsible Party):
McMaster University
ClinicalTrials.gov Identifier:
NCT02561169
First received: September 22, 2015
Last updated: September 24, 2015
Last verified: September 2015
  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: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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 ]

Estimated Enrollment: 940
Study Start Date: November 2015
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: April 2019 (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

Detailed Description:
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 firstly be defined as a non-elective admission to hospital, in contrast to return visits to the emergency department where admission does not take place, which will be classified separately. However, a prolonged stay in the emergency department (> 24 hours) will also be considered to be hospitalization. Hospitalizations, as well as all other outcomes, will be counted up to 28 days following randomization. Secondary outcomes will be lower respiratory tract infection, pneumonia, antimicrobial prescriptions, acute sinusitis, visits to medical providers and work related absenteeism for up to 28 days following randomization will be captured as secondary outcomes during the follow up.
  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02561169

Contacts
Contact: Mark Loeb, MD 905 525 9140 ext 26679

Locations
Canada, Alberta
Foothills Medical Centre Emergency Department Not yet recruiting
Calgary, Alberta, Canada, T2N 4W4
Contact: Eddy Lang, MD    (403) 943-7573    Eddy.Lang@albertahealthservices.ca   
Sub-Investigator: Richard Leigh, MD         
Principal Investigator: Eddy Lang, MD         
Rockyview General Hospital Not yet recruiting
Calgary, Alberta, Canada, T2V 1P9
Contact: Eddy Lang, MD    (403) 943-7573    Eddy.Lang@albertahealthservices.ca   
Northeast Community Health Centre Not yet recruiting
Edmonton, Alberta, Canada, T5A 5E4
Contact: Brian Rowe, MD    780-407-6707    Brian.Rowe@ualberta.ca   
University of Alberta - Emergency Department Not yet recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Brian Rowe, MD    780-407-6707    Brian.Rowe@ualberta.ca   
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
Study First Received: September 22, 2015
Last Updated: September 24, 2015

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

ClinicalTrials.gov processed this record on June 23, 2017