Research: GlaxoSmithKline - Clinical Trials of IV Zanamivir for treatment of Influenza for hospitalized patients

Mount Sinai Hospital is a University of Toronto patient care, teaching, and research centre.

A Phase III international, randomized, double-blind, doubledummy study to evaluate the efficacy and safety of 300 mg or 600 mg of intravenous zanamivir twice daily compared to 75 mg of oral oseltamivir twice daily in the treatment of hospitalized adults and adolescents with influenza

To assess the efficacy of treatment with 300 mg or 600 mg of intravenous (IV) zanamivir twice daily compared to 75 mg of oral oseltamivir twice daily on time to clinical response (TTCR).

To participate you must

Be 18 years or older
Have Influenza, with onset of influenza symptoms within 6 days prior to study enrolment
Be hospitalized due to severity of your medical illness for treatment and supportive care

You must not

Taken more than a total of 3 days of approved antiinfluenza therapy in the period from onset of symptoms and prior to enrolment
Require concurrent therapy with another influenza antiviral medication.
Have underlying chronic liver disease with evidence of severe liver impairment
Have a history of severe cardiac disease or clinically significant arrhythmia
Be a female who is pregnant or is breastfeeding.
Have a treatment with investigational parenteral anti-influenza drugs in the 4 weeks prior to Baseline.

You will be given study drug and placebo for 5 days, but this might continue for up to 10 days depending on your health. If your doctor feels you are not improving on the study drug, he can put you into another group where you will be treated with a predetermined dose of zanamivir for 5 days, so some people may have up to 14 days of treatment
You will need to get tests, and we will record any changes in your health and medicines. If you remain in hospital for the entire study, all of the tests and follow-ups will be done during your stay. If you are well enough to go home while taking part in the study, we will telephone you regularly to check your health, and to see if you are taking any new medicines. Depending on when you go home, you may need to come back to the hospital for one or two follow-up visits, and at the end of the study for final tests.

If you would like to learn more about the study, please email aabdullayeva@mtsinai.on.ca or call Afat at 416-586-4800 ext. 2764, pager 416-380-5118

Dr. Allison McGeer

This website has been made possible through an unrestricted educational grant from Pfizer Canada Inc.