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

Sponsor

McMaster University (Other)

Overall Status

Terminated

CT.gov ID

NCT02561169

Collaborator

University of Calgary (Other), University of Alberta (Other)

Enrollment

Location

Arms

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Influenza	Drug: Oseltamivir Other: Placebo	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

1 participants

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

Study Start Date :

Dec 1, 2015

Actual Primary Completion Date :

Mar 1, 2016

Actual Study Completion Date :

Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: Calcium Carbonate

Arm

Intervention/Treatment

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 Names:

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 Names:

Calcium Carbonate

Outcome Measures

Primary Outcome Measures

Non-elective Hospitalizations (number of hospitalizations) [28 days]
Length of non-elective hospitalization (days) [28 days]

Secondary Outcome Measures

Lower respiratory tract infection (LRTI), (number of LRTIs) [28 days]
Pneumonia (number of episodes of pneumonia) [28 days]
Acute Sinusitis (number of episodes of acute sinusitis) [28 Days]
New antimicrobial prescription (number of antimicrobial prescriptions) [28 Days]
Medical visits for acute respiratory illness (number of medical visits) [28 Days]
Death [3 months]
Adverse Events (number of adverse events) [5 days]
Admission to intensive or critical care unit (number of admissions) [28 days]
Duration of stay in intensive or critical care unit (days) [28 days]
Need for mechanical ventilation (number of mechanical ventilation) [28 days]
Duration of mechanical ventilation (days) [28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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