NCT02561169

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2015

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 25, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

August 4, 2017

Status Verified

August 1, 2017

Enrollment Period

3 months

First QC Date

September 22, 2015

Last Update Submit

August 3, 2017

Conditions

Influenza

Keywords

antiviraloseltamivir

Outcome Measures

Primary Outcomes (2)

  • Non-elective Hospitalizations (number of hospitalizations)

    28 days

  • Length of non-elective hospitalization (days)

    28 days

Secondary Outcomes (11)

  • 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

  • +6 more secondary outcomes

Study Arms (2)

Oseltamivir

EXPERIMENTAL

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

Drug: Oseltamivir

Placebo

PLACEBO COMPARATOR

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

Interventions

OseltamivirDRUG

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.

Also known as: Tamiflu
Oseltamivir
PlaceboOTHER

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.

Also known as: Calcium Carbonate
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foothills Medical Centre Emergency Department

Calgary, Alberta, T2N 4W4, Canada

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

OseltamivirCalcium Carbonate

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsCalcium CompoundsInorganic ChemicalsCarbonatesCarbonic AcidCarbon Compounds, InorganicMinerals

Study Officials

  • Mark Loeb, MD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2015

First Posted

September 25, 2015

Study Start

December 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

August 4, 2017

Record last verified: 2017-08

Locations

CA(1)