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

NCT ID: NCT02561169

Last Updated: 2017-08-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2016-03-31

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.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: TRIPLE

Study Groups

Oseltamivir

75 mg oseltamivir orally twice daily for 5 days within 72 hours of symptom onset

Group Type: EXPERIMENTAL

Oseltamivir

Intervention Type: DRUG

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.

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: OTHER

Other Intervention Names

Tamiflu; Calcium Carbonate

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Calgary

OTHER

Sponsor Role: collaborator

University of Alberta

OTHER

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Loeb, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

Foothills Medical Centre Emergency Department

Calgary, Alberta, Canada

Countries

Canada

Other Identifiers

Oseltamivir - 2015

Identifier Type: -

Identifier Source: org_study_id