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

NCT02561169 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2017-08-04

No results posted yet for this study

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

Interventions

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

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.

Sponsors & Collaborators

  • University of Calgary

    collaborator OTHER

  • University of Alberta

    collaborator OTHER

  • McMaster University

    lead OTHER

Principal Investigators

  • Mark Loeb, MD · McMaster University

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • Canada

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02561169 on ClinicalTrials.gov