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

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02561169
• Other study ID #: Oseltamivir - 2015
• Status: Terminated
• Phase: Phase 4
• First received: September 22, 2015
• Last updated: August 3, 2017
• Start date: December 2015
• Est. completion date: March 2016

Study information

• Verified date: August 2017
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Influenza
• Influenza, Human

Intervention

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.

Locations

Country	Name	City	State
Canada	Foothills Medical Centre Emergency Department	Calgary	Alberta

Sponsors (3)

Lead Sponsor	Collaborator
McMaster University	University of Alberta, University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-elective Hospitalizations (number of hospitalizations)		28 days
Primary	Length of non-elective hospitalization (days)		28 days
Secondary	Lower respiratory tract infection (LRTI), (number of LRTIs)		28 days
Secondary	Pneumonia (number of episodes of pneumonia)		28 days
Secondary	Acute Sinusitis (number of episodes of acute sinusitis)		28 Days
Secondary	New antimicrobial prescription (number of antimicrobial prescriptions)		28 Days
Secondary	Medical visits for acute respiratory illness (number of medical visits)		28 Days
Secondary	Death		3 months
Secondary	Adverse Events (number of adverse events)		5 days
Secondary	Admission to intensive or critical care unit (number of admissions)		28 days
Secondary	Duration of stay in intensive or critical care unit (days)		28 days
Secondary	Need for mechanical ventilation (number of mechanical ventilation)		28 days
Secondary	Duration of mechanical ventilation (days)		28 days